BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN SDS BALLOON CATHETER

    MDR report key: 800495 · Received December 28, 2006

    Report

    Report Number
    6000089-2006-02650
    Event Type
    Injury
    Date Received
    December 28, 2006
    Date of Event
    November 28, 2006
    Report Date
    November 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    k011889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) #K011909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBCLAVIAN ARTERY TREATMENT PROCEDURE, "THE DISTAL END OF THE BALLOON CAME OFF IN A PT. BALLOON WAS INFLATED, DURING REPOSITIONING OF THE STENT, WITH VERY LITTLE FORCE WAS BEING USED, THE DISTAL END OF THE CATHETER WITH A BALLOON ON IT SHEARED OFF." THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE BALLOON WITH A SNARE AND NO PIECES OF THE BALLOON REMAIN INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MFR'S BALLOON. CURRENT PT STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 8807043

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention