BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC/ENCORE/ADVANTAGE

    MDR report key: 1061297 · Received June 13, 2008

    Report

    Report Number
    2134265-2008-01693
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDINGS, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, SIGNIFICANT BLOOD LOSS OCCURRED. THE PHYSICIAN USED AN ENCOURE ADVANTAGE 26 INFLATION DEVICE, BUT THE TOUHY OF THE DEVICE LEAKED THROUGHOUT THE CASE. THE TOUHY WOULD NOT CREATE A TIGHT SEAL CAUSING THE PT TO LOSE A SIGNIFICANT AMOUNT OF BLOOD, ESTIMATED BY THE PHYSICIAN TO BE "1.5 TO 2 UNITS". THE PT DID NOT RECEIVE ANY TREATMENT FOR THE BLOOD LOSS AND DID NOT HAVE A PROLONGED HOSPITAL STAY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. PT STATUS POST PROCEDURE IS NOTED AS FINE. ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC/ENCORE/ADVANTAGE MAV SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC NA 2042156

    Patients

    Seq Age Sex Outcome Treatment
    1 Other