BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2944240 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00462
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 ID # 2134265-2013-00460. IT WAS REPORTED THAT DURING A TUNNEL LINE SHEATHPLASTY PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDEWIRE. AS THE DEVICES WERE USED INSIDE THE PATIENT ANATOMY THE MUSTANG BALLOON CATHETER BECAME STUCK ON THE AMPLATZ STIFF GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49186 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK531

    Patients

    Seq Age Sex Outcome Treatment
    1