BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT ALL STAR WIRE 0.014

    MDR report key: 3143278 · Received April 15, 2013

    Report

    Report Number
    3143278
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ELECTIVE PCI OF THE CIRCUMFLEX ARTERY. PRIOR TO FINAL BALLOON INFLATION AT THE STENT SITE "ALL STAR 0.014" WIRE WAS PLACED BETWEEN STENT AND BALLOON BETTER SUPPORT. AFTER BALLOON INFLATION RADIOPAQUE PORTION OF THE WIRE SEPARATED FROM THE BODY OF THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162097 HT ALL STAR WIRE 0.014 ALL STAR DQX ABBOTT VASCULAR 0.014" 2101201

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R