BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUSION BALLOON CATHETER

    MDR report key: 1062662 · Received June 16, 2008

    Report

    Report Number
    2939204-2008-00229
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE, THE BALLOON SUDDENLY BURST. THE PHYSICIAN REMOVED THE BALLOON AND COMPLETED THE PROCEDURE WITH ANOTHER SIMILAR DEVICE. THERE WERE NO ALLEGATIONS OF HARM. NO FURTHER INFO WAS DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON CATHETER OCCLUSION BALLOON LIT BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION 17-103 11268103

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR