BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATB ADVANCE PTA DILATION CATHETER

    MDR report key: 1060550 · Received June 12, 2008

    Report

    Report Number
    1820334-2008-00292
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 15, 2008
    Manufacturer
    COOK INC
    Product Code
    DQY
    PMA / PMN Number
    K052036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL - STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS THE ATB BALLOON WAS PULLED BACK THROUGH A 6 FRENCH PERFORMER SHEATH DURING A FISTULOPLASTY, THE BALLOON GOT CAUGHT ON THE DISTAL END OF THE SHEATH AND WOULD NOT PULL THROUGH THE SHEATH. THE BALLOON SHAFT BEGAN TO ACCORDION AND BROKE WITH THE BALLOON STILL INTACT. THE BALLOON AND SHEATH SYSTEM WERE REMOVED FROM THE PT'S FISTULA GRAFT AS ONE UNIT. NO HARM OR BLOOD-LOSS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATB ADVANCE PTA DILATION CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC NA 2065884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK