BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1852124 · Received September 28, 2010

    Report

    Report Number
    9710478-2010-00122
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DILATATION BALLOON RUPTURED AT 14 ATMOSPHERES. WHEN THE BALLOON WAS REMOVED FROM THE PT, THE OUTER MATERIAL OF THE BALLOON WAS NOTED TO HAVE TORN AND SEPARATED INTO TWO PIECES. THE LESION WAS IN A MODERATELY CALCIFIED COMMON ILIAC. THERE WAS NO REPORTED RESISTANCE REMOVING THE DEVICE FROM THE PT. IT WAS CONFIRMED THAT ALL PIECES WERE REMOVED FROM THE PT. THE PT IS FINE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 649676

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK