BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1060041 · Received June 11, 2008

    Report

    Report Number
    3005099803-2008-00675
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, 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

    SAME CASE AS MFR REPORT#: 3005099803-2008-00674. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE BALLOON RUPTURED. THE BALLOON RUPTURED IN THE COMMON BILE DUCT DURING THE PROCEDURE. A SECOND BALLOON ALSO RUPTURED DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS AND THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON BILIARY STONE RETRIEVAL BALLOON CATHETER FGE BOSTON SCIENTIFIC CORK LTD. M00546910

    Patients

    Seq Age Sex Outcome Treatment
    1