BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY

    MDR report key: 3072534 · Received April 18, 2013

    Report

    Report Number
    3006010712-2013-00016
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH HISTORY REVIEW WAS CARRIED OUT WHICH DEMONSTRATED THAT THE GUIDEWIRE WAS MANUFACTURED TO SPEC. A F/U REPORT WILL BE SENT ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PER SR: MALE PT OVER THE AGE OF (B)(6); VERY HEAVILY CALCIFIED LEFT SFA; POPLITEAL ARTERY ACCESSED WITH PT IN PRONE POSITION; ATTEMPTED TO CROSS LESIONS WITH SPECTRANETICS QUICK CROSS CATHETER AND VICTORY 18 25 GM WIRE. AFTER MULTIPLE TIMES REMOVING AND REINSERTING WIRE THROUGH QUICK CROSS CATHETER, PHYSICIAN SAID WIRE WAS "STICKY" AND EXPERIENCED SIGNIFICANT RESISTANCE TO THE POINT THAT WIRE WAS UNUSABLE. ATTEMPTED VICTORY 18 30 GM WIRE NEXT AND SAME THING HAPPENED. LATER IN THE CASE A VICTORY 14 12 HM WIRE WAS ADVANCED THROUGH A COYOTE BALLOON. UPON ATTEMPTED REMOVAL OF THE VICTORY 14 WIRE, SIGNIFICANT RESISTANCE WAS MET AND UPON REMOVAL IT WAS NOTICED THAT PART OF THE TIP OF THE WIRE HAD SHEARED BUT DID NOT COMPLETELY DETACH. THE ENTIRE WIRE WAS REMOVED FROM PT IN ONE PIECE. NEXT ATTEMPTED TO ADVANCE A JOURNEY WIRE THROUGH THE SAME COYOTE BALLOON. WHEN THE JOURNEY WIRE WAS REMOVED, PART OF THE TIP WAS MISSING. THERE WERE NO FOREIGN BODIES VISIBLE IN THE PT SO THE COYOTE BALLOON WAS REMOVED FROM THE PT AND FLUSHING WAS ATTEMPTED. AFTER MULTIPLE FAILED ATTEMPTS TO FLUSH, THE BACK END OF THE JOURNEY WIRE WAS INSERTED INTO THE COYOTE BALLOON AND THE MISSING PIECE OF JOURNEY TIP WAS PUSHED THROUGH THE TIP OF THE COYOTE BALLOON. THIS WAS ALL DONE ON THE SCRUB TABLE, OUTSIDE OF THE PT. NO FOREIGN BODIES WERE LEFT IN THE PT AND NO HARM CAME TO THE PT AS A RESULT OF THIS. THE CASE WAS ABORTED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168307 VICTORY GUIDEWIRE DQX BRIVANT, LTD. 901023-18 10156997

    Patients

    Seq Age Sex Outcome Treatment
    1 Other