BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1872462 · Received October 12, 2010

    Report

    Report Number
    9710478-2010-00130
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DILATATION OF A RESTENOSED, NON-ABBOTT STENT IN THE RIGHT SUBCLAVIAN VEIN, THE FOX PLUS BALLOON RUPTURED AT 12 ATMOSPHERES. THE ENTIRE BALLOON WAS REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 623225

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR