BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    MDR report key: 1190296 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02914
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AV FISTULA PROCEDURE, A BALLOON DISLODGEMENT OCCURRED. THE 80% STENOTIC LESION WAS LOCATED IN THE BASILLIC VEIN. THE ULTRATHIN STENT DELIVERY SYSTEM (SDS) BALLOON DISLODGED FROM THE CATHETER POST INFLATION. THE NUMBER OF INFLATIONS AND TO WHAT ATM'S ARE UNK. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE DISLODGED BALLOON USING A SNARE; NO FRAGMENTS REMAINED IN THE PT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PT COMPLICATIONS WERE REPORTED. THE PT'S STATUS WAS REPORTED AS SATISFACTORY. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0011848857

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention