BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1191902 · Received October 1, 2008

    Report

    Report Number
    9710478-2008-00129
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE INVESTIGATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, DURING PRE-DILATATION, THE FOX PLUS BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE BODY AND DILATATION WAS COMPLETED USING A NON-ABBOTT BALLOON. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 503297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK