BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBW OCCLUSION BALLOON

    MDR report key: 839473 · Received October 11, 2006

    Report

    Report Number
    6000118-2006-00066
    Event Type
    Malfunction
    Date Received
    October 11, 2006
    Date of Event
    September 10, 2006
    Report Date
    September 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE IN THE AORTIC ARCH, THE OCCLUSION BALLOON RUPTURED. WHEN THE BALLOON WAS FILLED WITH THE PRESCRIBED AMOUNT OF SALINE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. THIS EVENT OCCURRED OUTSIDE THE PATIENT'S BODY DURING PREPARATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OCCLUSION BALLOON WITH NO PATIENT COMPLICATIONS. CURRENT PATIENT CONDITION IS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBW OCCLUSION BALLOON OCCLUSION BALLOON DQX BOSTON SCIENTIFIC NA 7781417

    Patients

    Seq Age Sex Outcome Treatment
    1 YR