BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 2920667 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00348
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2013-00073. IT WAS REPORTED THAT DURING A DILATION TREATMENT PROCEDURE, THE CATHETER FROZE ON THE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL ANTERIOR TIBIAL BELOW THE KNEE. THIS ULTRA-THIN DIAMOND BALLOON CATHETER WAS SELECTED; HOWEVER, DURING INTRODUCTION THE BALLOON CATHETER BECAME KINKED AND STUCK ON THE 0.35" ZIPWIRE GUIDE WIRE. ONCE WITHDRAWN FROM THE PATIENT NO DAMAGE NOTED TO THE WIRE. THE PROCEDURE WAS COMPLETED WITH A 3X15MM STERLING BALLOON CATHETER AND A 0.018" NON-BSC GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25458 ZIPWIRE HYDROPHILIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE UNK493

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR