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CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Reports 1998-2010
Medical Device Brand Name: AGILITY-14
Medical Device Generic Name: CES GUIDEWIRES
Medical Device Manufacturer Name:CORDIS NEUROVASCULAR, INC.


CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 454543
THE PHYSICIAN WAS PERFORMING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE PHYSICIAN DID PARACENTESIS OF THE PORTAL VEIN. THEREAFTER, THE PHYSICIAN INSERTED THE GUIDEWIRE INTO THE PT'S PORTAL VEIN. THE TIP OF THE GUIDEWIRE SEPARATED AS THE PHYSICIAN WAS LOOKING FOR THE VESSEL ROUTE IN THE PT'S BODY. AN ATTEMPT TO REMOVE THE TIP WAS MADE; HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE GUIDEWIRE TIP REMAINS INSIDE THE PT'S PORTAL VEIN. HOWEVER, THE PT'S PRESENT CONDITION AT THE TIME OF THE REPORT WAS NOTED AS SATISFACTORY WITHOUT ANY COMPLICATIONS. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVAL IS NOT COMPLETE.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 454543
GUIDEWIRE SEPARATION.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 441625
THE WIRE BROKE OFF.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 441625
THE REPORT RECEIVED FROM THE FIELD INDICATED THAT, DURING AN ATTEMPT TO DEPLOY THE STENT THE WIRE BROKE OFF BUT THEY WERE ABLE TO RETRIEVE IT. THERE WERE NO COMPLICATIONS TO THE PATIENT. ADDITIONAL INFORMATION WAS OBTAINED: THE TARGET LESION WAS LEFT INTERNAL CAROTID ARTERY. THERE WAS TIGHT BEND IN THE LESION AND THE DELIVERY SYSTEM KNIKED. THE PYSICIAN ATTEMPTS TO PULLBACK THE WIRE AND THE FRACTURED OCCURRED. THE ENTIRE SYSTEM WAS PROCEDURE WAS COMPLETED. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER THE ENGINEERING EVALUATION IS NOT YET COMPLETE. PLEASE NOTE DATE OF 03/07/2003 FOR SUBMISSION OF SUCH INFORMATION.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 441625
THE PRODUCT HAS BEEN RETURNED FOR EVALUAITON AND TESTING, HOWEVER, THE ENGINEERING EVALAUTION IS NOT YET COMPLETE. PLEASE NOTE DATE OF 04/03 FOR SUBMISSION OF SUCH INFO.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 441625
THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. PLEASE NOTE DATE OF 05/2003 FOR SUBMISSION OF SUCH INFO.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 441625
THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING, HOWEVER, THE ENGINEERING EVAL IS NOT YET COMPLETE. PLEASE NOTE DATE OF 04/04/03 FOR SUBMISSION OF SUCH INFO.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 656235
INFORMATION RECEIVED FORM THE AFFILIATE ORIGINALLY STATED, "THE TIP OF THE GUIDWIRE WAS KINKED DURING THE PROCEDURE". THERE WAS NO PATIENT OR PROCEDURAL INFORMATION AVAILABLE. THERE WAS NO INJURY TO THE PATIENT. THIS WAS ORIGINALLY DETERMINED TO BE A NOT REPORTABLE MALFUNCTION UNDER THE MEDICAL DEVICE REGULATION GUIDELINES. WHEN THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING IT WAS NOTED THAT THE DISTAL END OF THE COIL-WIRE WAS ELONGATED AND FRACTURED, BUT NOT SEPARATED, FROM THE DISTAL TIP. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PRODUCT LOOKED NORMAL WHEN IT WAS TAKEN FROM THE PACKAGING AND THE AFFILATE BELIEVES THAT THE DAMAGE TO THE WIRE DID NOT OCCUR DURING SHIPPING. AS PER THE QUALRAP, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AS TO THE CHARACTERISTICS OF THE VESSEL, THE PATIENT, OR THE PROCEDURE.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 656235
THERE IS NOT ENOUGH INFORMATION AVAILABLE TO DETERMINE IF PATIENT OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORT OF THE KINKED GUIDEWIRE OR TO THE ELONGATION AND FRACTURE OF THE RETURNED PRODUCT. NO CONCLUSION CAN BE MADE. THE REPORTED COMPLAINT FOR KINKING WAS NOT CONFIRMED, ALTHOUGH A FRACTURE OF THE COREWIRE WITHIN THE TIP SECTION WAS CONFIRMED. MANUFACTURING RECORDS WERE REVIEWED AND RESULTS INDICATE THAT PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. EXAMINATION SUGGESTS THE FRACTURED COREWIRE WAS CAUSED BY A TENSILE OVERLOAD WITH A BENDING MOMENT. THE FRACTURE OF THE COREWIRE APPEARS TO BE RELATED TO THE PROCEDURE.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 640319
ADDITIONAL INFORMATION WAS RECEIVED. THE PT HAS BEEN DHSCHARGED FROM THE HOSP AND SHOWED NO SYMPTOMS. THIS IS TWO FOUR UNITS USED ON THE SAME PT. MFR REPORT # 1058194-2006-11115

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 640319
ADDITIONAL INFO WAS REC'D. REPORTEDLY TWO AGILITY 10 AND TWO AGILITY 14 GUIDEWIRES WERE USED ON THE SAME PT, AND THEY FRACTURED WITHIN THE LESION, THE FOURTH TIP FRACTURED GUIDEWIRE WAS RETRIEVED. BOTH GUIDEWIRES WERE REC'D COILED WITHIN A PLASTIC BAG. THE DISTAL TIP COREWIRE AND COILWIRE OF BOTH RETURNED GUIDEWIRES WERE COMPLETELY FRACTURED. THE DISTAL FRACTURE SEGMENTS OF BOTH WRIE TIPS WERE NOT RETURNED FOR EXAMINATION. ELECTRON OPTICAL MICROSCOPY WAS PERFORMED ON THE FRACTURE SITES OF THE TWO RETURNED GUIDEWIRES. THE COREWIRE FRACTURE SURFACE OF BOTH RETURNED GUIDEWIRES. THE COREWIRE FRACTURE SURFACE OF BOTH RETURNED SPECIFMENTS EXHIBITED A CIRCULAR ARRAY OF MATERIAL AND A TRANSVERSE FRACTURE PLANE. THE COILWIRE FRACTURE ENDS WERE NECKED DOWN. EVIDENCE SUGGESTS THE FRACTURE OF THE COREWIRES WAS THE RESULT OF A TORSIONAL OVERLOAD AND THE COILWIRE FRACTURES WERE CAUSED BY A TENSILE OVERLOAD. NO EVIDENCE OF ANY MATERIAL DEFECTS WERE NOTED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 640319
REPORTEDLY, THE PHYSICIAN USED UROKINASE (UK) TO DISSOLVE THE STENOSIS IN THE MIDDLE CEREBRAL ARTERY (MCA) ON PATIENT THAT ARRIVED 6 HOURS AFTER THE ONSET OF A STROKE. HE THEN WAS ADVANCING THE AGILITY GUIDEWIRE INTO THE MIDDLE CEREBRAL ARTERY WITH THE INTENT TO USE THE WIRE TO PHYSICALLY UNBLOCK THE STENOTIC LESION. THIS MICROWIRE PASSED THE LESION BUT FAILED TO BE RETRIEVED AND DISCONNECTED AND SOME OF THE DISTAL PART WAS LEFT ON THE LESION. WHEN THIS PART WAS DISCONNECTED, THE ONE TIP OF THIS PART ENTERED THE SIDE BRANCH OF MCA, ALIGNING LIKE LETTER `V'. THE DOCTOR TRIED TO TAKE THIS PART OUT OF THE MCA WITH ANOTHER AGILITY AFTER SHAPING THE TIP OF THE MICROWIRE IN ORDER TO MAKE EASY TO RETRIEVE THE BROKEN PART. HOWEVER, IT WAS UNSUCCESSFUL AND THE TIP OF THE SECOND AGILITY GUIDEWIRE SEPARATED AND REMAINED AS WELL IN THE VESSEL. HE AGAIN ATTEMPTED WITH THE THIRD AGILITY GUIDEWIRE AND ALSO THE TIP SEPARATED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 640319
AFTER ABOUT FOUR HOURS LATER, THE UK WAS DISSOLVED THE CLOT WELL AND HE DID NOT ATTEMPT TO SNARE THE WIRE TIPS AND THEY REMAINED WITHIN THE VESSEL. THE PT AGREED WITH THE PHYSICIAN'S DECISION. ANOTHER NEW AGILITY GUIDEWIRE WAS INSERTED AND WORKED FINE. IT WAS REPORTED THAT THE PRODUCT WAS MISUSED BY THE PHYSICIAN ALTHOUGH THE PHYSICIAN WAS AWARE OF THE IFU AND ADMITTED THE MIS-USE. THE PATIENT CONDITION WAS BETTER THAN WHEN SHE WAS FIRST TRANSFERRED TO HOSPITAL AND SHE SHOWED SOME MOTOR ACTIVITY AFTER THE PROCEDURE, BUT IS STILL IN A COMA. IT WAS REPORTED THAT THERE WERE NO NEUROLOGICAL CHANGES ATTRIBUTED TO THE AGILITY WIRES THAT BORKE OFF. AFTER THE PHYSICIAN TRIED TO MECHANICALLY OPEN THE LESION WITH THE AGILITY WIRE, THE BLOOD FLOW HAD IMPROVED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 633460
A LETTER WAS RECEIVED FROM THE DR DESCRIBING THE EVENT: DURING A SPINAL ANGIOGRAPHY AND INTERVENTION, A PROWLER 14 CATHETER WAS NAVIGATED OVER A 0.014" SOFT GUIDE WIRE (CORDIS PRODUCT NUMBER 614482). DURING INTRAVASCULAR NAVIGATION OF THE GUIDE WIRE THROUGH ONE OF THE INTERCOSTAL ARTERIES, THE WIRE WRAPPED AROUND ITSELF MAKING A BEND AND COULD NOT BE REMOVED THROUGH THE MICROCATHETER. UPON INCREASED RETRIEVAL FORCE, THE WIRE BROKE AFTER INITIALLY UNRAVELING AT THE JUNCTION BETWEEN THE DISTAL TIP (APPROXIMATELY 10 MM) AND THE SHAFT OF THE WIRE. THE BROKEN WIRE WAS LEFT IN PLACE AND IT DID NOT COMPROMISE THE FLOW IN THE INTERCOASTAL ARTERY. THE PT WAS KEPT ON HEPARIN AND ANTIPLATELET AGENTS. THE PROCEDURE WAS TERMINATED AS PLANNED. THE FLOW WITHIN THE INTERCOSTAL ARTERY WAS REPEATED AGIOGRAM, UNREMARKABLE. ADDITIONAL INFO RECEIVED FROM THE DR REPORTED THAT THE WIRE BROKE AFTER INITIALLY UNRAVELING AT THE JUNCTION BETWEEN THE DISTAL TIP (APPROXIMATELY 10 MM) AND THE SHAFT OF THE WIRE. THE WIRE BROKE IN THE ORIGIN OF THE INTERCOSTAL ARTERY T7, NOT THE VERTEBRAL ARTERY. THE BROKEN WIRE WAS LEFT IN PLACE AND IT DID NOT COMPROMISE THE FLOW IN THE INTERCOSTAL ARTERY. THE NEUROLOGICAL SYMPTOMS WERE NOT ASSOCIATED WITH THE WIRE BUT WITH THE UNDERLYING DISEASE.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 633460
DURING AN EMBOLIZATION OF A SPINAL MENIGIOMA ON A PATIENT, AS THE PHYSICIAN WAS ADVANCING THE AGILITY WIRE IT WAS TORQUED AND THE WIRE BROKE. A PORTION OF THE WIRE, UNKNOWN HOW MUCH, WAS LEFT IN THE RIGHT VERTEBRAL ARTERY AT THE T7 SEGMENT. IT WAS REPORTED THAT AFTER THE PROCEDURE THE PATIENT WAS EXPERIENCING SOME PARALYSIS FROM THE WAIST DOWN. FIVE DAYS LATER THERE WAS MINIMAL MOVEMENT OF THE LOWER EXTREMETIES. THERE WAS NO INFORMATION PROVIDED REGARDING THE BASELINE STATUS OF THE PATIENT.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 599071
THE GUIDEWIRE FRACTURED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 599071
DURING TREATMENT OF AN ANEURYSM IN THE MCA, THE CLINICIAN TRIED ORIGINALLY TO ADVANCE THE TRUDILL DCS THROUGH A PROWLER 14 CATHETER, FOLLOWING POSITIONING WITH AGILITY GW. IT WAS THEN REALIZED THAT THE COIL WAS INCOMPATIBLE. THE GUIDEWIRE WAS REMOVED AND THE AGILITY WAS FOUND TO BE BROKEN. THE MISSING LENGTH WAS FOUND IN THE MICROCATHETER. A PROWLER PLUS CATHETER WAS PLACED. THE COIL WOULD NOT ADVANCE THROUGH THE PROWLER PLUS. THE AGILITY GUIDEWIRE, THE PROWLER 14 AND THE COIL ARE TO BE RETURNED FOR EVALUATION AND TESTING, BUT THESE HAVE NOT BEEN YET RECEIVED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 786820
THE THIRD COIL STRETCHED. DURING COIL EMBOLIZATION WITHIN A NON-CALCIFIED/TORTUOUS 7X8MM ANEURYSM, TWO ORBIT COILS WERE PLACED WITHOUT DIFFICULTY. DURING PLACEMENT OF THIRD ORBIT COIL, THE COIL STRETCHED. THIS COIL WAS REMOVED AND ANOTHER ORBIT COIL WITH THE SAME MICROCATHETER (PROWLER 14) USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PT. REPORTEDLY, THE COIL WAS WITHDRAWN INTO THE MICROCATHETER WITHOUT DIFFICULTY. DURING PLACEMENT, 30% OF THE COIL WAS OUT OF THE MICROCATHETER. THERE WAS NO RESISTANCE, WHEN THE COIL WAS REPOSITIONED/WITHDRAWN. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MICROCATHETER. PRIOR TO USE, THE MICROCATHETER WAS RE-SHAPED USING A MANDREL. THE COIL WAS NOT OUT OF THE MICROCATHETER, WHEN THE MICROCATHETER WAS BEING REPOSITIONED.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 786820
BASED ON THE ANALYSIS OF THE RETURNED PRODUCT, WHICH THE COIL WAS IN THE INTRODUCER AND CONTAINED LOOSE MATERIAL APPEARED TO BE PTFE COATING OF THE GUIDEWIRE. THIS GUIDEWIRE IS BEING REPORTED AS MALFUNCTION. REPORTEDLY, THERE WAS NO RESISTANCE INSERTING THE GUIDEWIRE INTO THE MICROCATHETER. THE GUIDEWIRE WAS NOT RE-SHAPED, PRIOR TO USE. THERE WERE NO ABNORMALITIES NOTED ON THE GUIDEWIRE AT ANYTIME DURING THE PROCEDURE OR AFTER ITS REMOVAL. UPON REMOVAL OF THE COIL FROM THE MICROCATHETER, THE COIL WAS STILL ATTACHED TO THE GRIPPER. THE PHYSICIAN PUT THE COIL AND GUIDEWIRE TOGETHER AFTER THE PROCEDURE. THE PRODUCT WILL NOT RETURNED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PT. MFR REPORT# 1058196-2006-00177 & MFR REPORT # 1058196-2006-00198.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 746447
NI

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 746447
REPORT RECEIVED INDICATED THAT DURING A PERCUTANEOUS BALLOON DILATATION OF THE PULMONARY ARTERY THE GUIDEWIRE (GW) SEPARATED AND WAS UNABLE TO BE RETRIEVED FROM THE BODY. PROCEDURE WAS BEING PERFORMED ON A CHILD. DEVICE WAS PREPPED AND USED FOLLOWING THE INSTRUCTIONS FOR USE (IFU). LESION WAS NOT CALCIFIED. THE INITIAL GW (AQUA) WAS NOT ABLE TO CROSS THE LESION THEREFORE A SECOND GW (AGILITY 614-481) WAS USED CROSSING THE LESION SUCCESSFULLY. SUBSEQUENTLY THREE BALLOON CATHETERS WERE ADVANCED TOWARDS THE LESION OVER THE GW DILATING LESION SUCCESSFULLY. AFTER LESION DILATION AN ATTEMPT TO REMOVE THE GW WAS MADE HOWEVER THERE WAS RESISTANCE. IT WAS REPORTED THAT THE WIRE WAS "CAUGHT". ATTEMPTS TO REMOVE THE GW WERE CONTINUED, HOWEVER DEVICE TIP SEPARATED 5 CM FROM THE DISTAL EDGE. AN EFFORT WAS MADE TO REMOVE THE TIP OF THE GW FROM THE VESSEL HOWEVER THE TIP COULD NOT BE REMOVED AND REMAINS IN THE PULMONARY ARTERY. PATIENT IS ASYMPTOMATIC. THIS PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 725450
THIS 76 Y/O FEMALE PATIENT WITH A DIAGNOSIS OF HUNT & HESS GRADE IV AND HISTORY OF DIABETES AND HYPERTENSION WAS UNDERGOING COIL EMBOLIZATION WITHIN THE RUPTURED ANEURYSM ON 09/08/04. ANEURYSM SIZE 3MM X 3MM, X 4MM, NECK SIZE 2MM, NECK/SAC RATIO .67. TWO COILS (3X8 & 2X8) WERE PLACED WITHIN THE LEFT MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE THE PATIENT HAD THROMBOEMBOLIC EVENT, BUT IT WAS REPORTED AS UNRELATED TO THE PRODUCT. ADDITIONAL INFORMATION WAS OBTAINED FROM THE PHYSICIAN: THE THROMBOEMBOLIC EVENT HAPPENED DURING PROCEDURE. THE ANEURYSM WAS IN M1 BIFURCATION. THROMBUS HAD IN M2 BRANCH DURING COILING PROCEDURE. IT IS RELATED TO PROCEDURE BUT IT IS NOT POSSIBLE TO TELL IF IT IS RELATED TO COILS OR MICRO CATHETER OR SOMETHING ELSE BECAUSE THIS IS INDIVIDUAL REACTION OF HUMAN BODY. ADDITIONAL DOSE OF HEPARIN IV WAS ADMINISTERED AND THROMBUS DISAPPEAR WITHOUT ANY CLINICAL CONSEQUENCES. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. PLEASE NOTE THAT THIS MEDWATCH REPRESENTS ONE OF FOUR PRODUCTS THAT WAS INVOLVED IN THIS EVENT AND IS RELATED TO MFG# 105196-2006-00093, 105196-2006-00088, 1058196-2006-00088, 1058196-2006-00082. 1058196-2006-00081.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 721835
DURING PRE-SHAPING OF THE GUIDEWIRE, PRIOR TO INSERTING IN THE PATIEN, THE DISTAL TIP UNRAVELED. THERE WAS NO PATIENT INJURY REPORTED WITH THE EVENT.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 721835
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 691383
DURING COIL EMBOLIZATION OF AN ANEURYSM, WHILE ADVANCING THE GUIDEWIRE (GW) THROUGH THE MICROCATHETER EXCEL 18 BS (MC), THE PHYSICIAN NOTED THAT THE COATING OF THE GW WAS STRIPPED AWAY. THE MC AND GW WERE REMOVED AS A UNIT FROM THE PT'S VESSEL WITHOUT ANY DIFFICULTY. A NEW MC AND GW WERE USED TO COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PT. REPORTEDLY, THE GW WAS INSPECTED PRIOR TO USE AND NO KINK OR PROBLEMS WERE IDENTIFIED. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MC.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 689175
THE WIRE TIP WAS STRETCHED WHILE THE PHYSICIAN WAS ADVANCING/WITHDRAWING THE GUIDEWIRE AT THE NECK OF ANEURYSM. THE EVENT HAPPEN BEFORE ANY MICRO CATHETER WAS IN THE CEREBRAL VASCULAR. THERE WAS NO REPORT OF PATIENT INJURY.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 845150
AFTER EXPERIENCING POOR TORQUE RESPONSE WITH AN AGILITY GUIDEWIRE (GW), THE DEVICE FRACTURED AND SEPARATED. POOR TORQUE RESPONSE WITH ENCOUNTERED WITH A SECOND AGILITY WIRE. THE PRODUCTS WERE BEING USED FOR THE TREATMENT OF A BASILAR TIP ARTERY. AFTER RESHAPING, THE FIRST GW WAS INSERTED INTO THE UNKNOWN PROWLER MICROCATHETER (MC) AND INSERTED INTO THE GUIDE CATHETER (GC) THAT WAS POSITIONED IN THE PARENT ARTERY. THERE WAS NO RESISTANCE INSERTING THE GW INTO THE MC OR RESISTANCE MANEUVERING THROUGH THE MC. THE GW WAS ADVANCED OUT OF THE MC WITH THE DISTAL END IN THE VESSEL WHEN THE EVENT OCCURRED. TYPICALLY AND IN THIS EVENT, IT IS BELIEVED TO BE THE CASE, AFTER INTRODUCING 3-4 CM OF THE DISTAL END OF WIRE OUT OF THE MC, THE WIRE IS PURPOSELY PROLAPSED/LOOPED TO PREVENT IF FROM SUPER-SELECTING AN UNINTENDED TAKE-OFF VESSEL. IT WAS AT THIS TIME WHEN ATTEMPTING TO TORQUE THE AGILITY WIRE, THAT THERE WAS NO RESPONSE. THE TORQUING WAS CONTINUED AND THEN IT WAS NOTED THAT THE WIRE FRACTURED AND SEPARATED. FLUOROSCOPY WAS BEING USED DURING THIS EVENT. THE AREA THAT WAS FRACTURED WAS WITHIN THE MC. THE MC AND GW (IN IT'S ENTIRETY) WERE REMOVED AS A UNIT FROM THE PT. THE SAME PROWLER MC AND A NEW AGILITY WIRE WERE INSERTED AND AS SOON AS THE TORQUE RESPONSE WAS NOTED TO BE ABNORMAL, THE WIRE WAS REMOVED INTACT. THE SAME MC WAS USED WITH ANOTHER AGILITY WIRE FROM A DIFFERENT LOT WITHOUT ANY PROBLEMS.

CES GUIDEWIRES CORDIS NEUROVASCULAR, INC. Report # 845150
THE SECOND AGILITY WIRE WAS CONFIRMED TO BE BENT AND KINKED AT THE TIP WITH STRETCHED COIL WIRES, COATING DAMAGE AND A BEND AT 4.5 INCHES FROM THE DISTAL END. THE SPRING SECTION WAS FOUND OVERSTRETCHED IN THE MIDPOINT, BUT THE WIRE IS NOT BROKEN AND ALL JOINTS ARE INTACT. IT IS POSSIBLE THAT THE COILS WERE OVERSTRETCHED DURING THE RE-SHAPING OF THE DISTAL TIP PRIOR TO USE. THE OVERSTRETCHING OF THE GW COULD HAVE BEEN THE CAUSE OF THE TORQUING DIFFICULTY ENCOUNTERED WITH BOTH GWS. THE IFU WARNS THAT SPECIAL CARE SHOULD BE TAKEN WHEN SHAPING THE GW TIP IN ORDER TO PREVENT DAMAGE. THE DHR REVIEW WAS COMPLETED AND NO DEFECTS RELATED TO THIS COMPLAINT WERE FOUND. THE REPORTED COMPLAINT DOES NOT APPEAR TO BE MANUFACTURING RELATED, AND MAY TO BE RELATED TO PROCEDURAL FACTORS. COMPLAINTS OF THIS TYPE WILL CONTINUE TO BE MONITORED FOR TRENDING PURPOSES AND TO DETERMINE IF ACTION IS NECESSARY. THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PT, WHICH IS ASSOCIATED WITH MFG REPORT #1058196-2007-00061 AND 1058196-2007-00093.


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