BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX BALLOON DILATATION

    MDR report key: 596056 · Received April 21, 2005

    Report

    Report Number
    6000122-2005-00003
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Date of Event
    March 16, 2005
    Report Date
    March 22, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A THERAPEUTIC PROCEDURE ON A PT, THE BALLOON WOULD NOT INFLATE AT A TARGET LESION. THE PHYSICIAN THEN PULLED THE BALLOON FROM THE COMMON BILE DUCT. IT WAS THEN OBSERVED THAT APPROXIMATELY 1CM PROXIMAL TO THE BALLOON, THE SHAFT WAS ALMOST BROKEN. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE BALLOON; HOWEVER, THE SHAFT COMPLETELY, LEAVING THE SHAFT TIP AND THE BALLOON IN THE PT'S DUODENA. THE PHYSICIAN THEN SUCCESSFULLY REMOVED AND DETACHED TIP FROM THE PT WITH THE AID OF FORCEPS. THERE WAS NO ADVERSE AFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX BALLOON DILATATION BALLOON DILATATION LIT BOSTON SCIENTIFIC CORP. NA 7062474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other