BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME BALLOON CATHETER

    MDR report key: 1983326 · Received February 4, 2011

    Report

    Report Number
    3004066202-2011-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 19, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES SPA.
    Product Code
    DQY
    PMA / PMN Number
    K042537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE BALLOON CATHETER REVEALED THAT THE SHAFT IS KINKED AT THE DISTAL PART. VISUAL EXAMINATION OF THE BALLOON MATERIAL REVEALED THAT THERE IS A RADIAL BURST IN THE MIDDLE OF THE BALLOON. ALL PIECES OF THE BALLOON MATERIAL WERE RECOVERED WITHOUT SURGICAL INTERVENTION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MANUFACTURING PROCESS. THE EVENT HAS BEEN CONFIRMED; HOWEVER, THE EXACT CAUSE FOR THE EVENT IS UNK.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE BALLOON DEFLATED. NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIRAL XTREME BALLOON CATHETER DQY INVATEC INNOVATIVE TECHNOLOGIES SPA. NA 1B004117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA