BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOXCROSS PTA BALLOON

    MDR report key: 2993182 · Received February 27, 2013

    Report

    Report Number
    MW5029212
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOXCROSS PTA BALLOON RUPTURED INSIDE OF PT'S RIGHT FEMORAL ARTERY DURING INSUFFICIENT AT A PRESSURE OF 10; THE RATED BURST PRESSURE IS 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83916 FOXCROSS PTA BALLOON PTA BALLOON LIT ABBOTT VASCULAR 781607

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention