BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYSHAK II

    MDR report key: 791319 · Received November 16, 2006

    Report

    Report Number
    2523676-2006-00100
    Event Type
    Other
    Date Received
    November 16, 2006
    Date of Event
    October 13, 2006
    Report Date
    November 10, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DQY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THE INCIDENT HAS NOT YET BEEN MADE AVAILABLE FOR THE MFR TO EVALUATE. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THESE BALLOON CATHETERS ARE MANUFACTURED AND PURCHASED FROM NUMED, INC. ALL AVAILABLE INFO HAS BEEN FORWARDED TO NUMED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. AT THIS TIME, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: WHEN THEY WERE INSIDE THE PT, DURING INFLATION WHEN USING AN INFLATER, THE TIP OF THE BALLOON BROKE OFF OF THE SHAFT. UNABLE TO RETRIEVE PIECE OF BALLOON FROM PT. THE PT IS OK. ADD'L INFO PROVIDED BY SALES REP INDICATED THE BALLOON FRAGMENT REMAINS IN THE PT AND THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. THE SAMPLE HAS BEEN SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHAK II BALLOON DILATION CATHETER DQY B. BRAUN MEDICAL, INC. PDC 536 TT-3416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other