BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC BALLOON CATHETER

    MDR report key: 2864976 · Received September 24, 2010

    Report

    Report Number
    2864976
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: PERIPHERAL CASE INVOLVING THE RT SFA. (SUPERFICIAL FEMORAL ARTERY). COMPLICATION INVOLVED THE PERIPHERAL BALLOON DETACHED FROM THE CATHETER POST DILATATION, THE BALLOON PORTION OF THE CATHETER WAS LEFT IN THE SFA. PHYSICIAN USED A SNARE TO RETRIEVE THE BALLOON. NO HARM TO THE PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC BALLOON CATHETER BALLOON CATHETER DRE BOSTON SCIENTIFIC CORPORATION 12914842

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention