BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 2758770 · Received August 24, 2012

    Report

    Report Number
    2758770
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    May 2, 2012
    Report Date
    June 6, 2012
    Manufacturer
    MEDRAD, INC/BAYER HEALTH CARE
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A SHUNTOGRAM PROCEDURE USING AN OVER-THE-WIRE THROMBECTOMY SET, WHEN THE ANGIOJET 50CM CATHETER CRACKED. THERE WAS NO HARM OR DELAY OF PROCEDURE AND PROCEDURE WAS COMPLETED. PATIENT WAS DISCHARGED HOME THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE MEDRAD, INC/BAYER HEALTH CARE 6F OTW 126173

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR
    2 81 YR