BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 2111923 · Received June 2, 2011

    Report

    Report Number
    3003775027-2011-00021
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CORE WIRE OF THE GRAND SLAM WAS SEPARATED AT APPROXIMATELY 21 MM FROM THE TIP END. THE COIL WIRE WAS ELONGATED FROM THAT POINT AND SEPARATED. THE SECTION ADJACENT TO THE BREAKAGE SITE OF THE CORE WIRE WAS ROUNDLY BENT, AND STRIATION WAS OBSERVED ON THE BREAKAGE SURFACE OF THE CORE WIRE. FROM THE ANALYSIS OF THE RETURNED DEVICE AND THE INFORMATION PROVIDED ON THE PROCEDURE, IT IS PRESUMED THAT REPEATED BENDING FORCE WAS INADVERTENTLY APPLIED TO THE SECTION OF BREAKAGE DURING THE PROCEDURE, AND WHEN THE GUIDE WIRE WAS REMOVED WHILE THE RESISTANCE WAS OBSERVED; THE ACCUMULATED BENDING FORCE EXCEEDED THE PRODUCT DESIGN LIMIT SO THAT THE CORE WIRE BECAME SEPARATED. THE SEPARATED COIL WIRE MAY HAVE BEEN DUE TO BENDING AND/OR STRETCHING FORCE THAT MIGHT BE LOCALLY APPLIED TO THE ELONGATED COIL WIRE. THE WARNING SECTION OF THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. SEPARATION OR BREAKAGE OF GUIDE WIRE IS LISTED IN THE IFU AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO ANOMALIES NOTED FOR THIS LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX LESION. THE PROCEDURE WAS LONG AND DIFFICULT. THE ASAHI GRANDSLAM GUIDE WIRE WAS ABLE TO GET THROUGH THE LESION AND PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. ATTEMPTS WERE MADE TO STENT THE LESION WITH A 2.5 X 18 MM AND A 2.5 X 12 MM XIENCE V STENT, BUT BOTH DEVICES WERE UNABLE TO CROSS. A NON-ABBOTT STENT WAS FINALLY ABLE TO BE IMPLANTED. DURING THE PROCEDURE THE GUIDE WIRE LOST PLACEMENT SEVERAL TIMES, INCLUDING AFTER THE NON-ABBOTT STENT WAS DEPLOYED. THE GUIDE WIRE WAS RE-ADVANCED AND POST-DILATATION WAS PERFORMED. WHEN RETRACTING THE GUIDE WIRE, RESISTANCE WAS OBSERVED AND THE COILS BECAME STRETCHED OUT. THE GUIDE WIRE WAS REMOVED WITH THE GUIDE CATHETER AND ONCE OUTSIDE THE PATIENT, IT WAS NOTED THAT THE CORE HAD FRACTURED. NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 10028A061

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR STENT: TAXUS, XIENCE V 2.5 X 18MM, 2.5 X 12MM