BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOVAC SUCTION CANNULA

    MDR report key: 3120101 · Received May 13, 2013

    Report

    Report Number
    3120101
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    BALLOON LOCATED ON THE DISTAL END OF THE SUCTION CANNULA WOULD NOT DEFLATE. THE PHYSICIAN WAS UNABLE TO REMOVE CANNULA FROM THE BODY. ANOTHER DEVICE WAS USED TO PIERCE THE BALLOON, THUS ALLOWING THE PHYSICIAN TO REMOVE THE DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ANGIO-VAC A VENOUS THROMBECTOMY DEVICE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210819 ANGIOVAC SUCTION CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA DWE ANGIODYNAMICS * 105317

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR FAILED TO DEFLATE| A DEVICE WAS USED TO PIERCE THE BALLOON AFTER IT