BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1203625 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05310
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, AS IT WAS DISPOSED OF AT THE USER FACILITY. THE DEVICE HISTORY RECORD REVIEW AND REVIEW OF NON-CONFORMANCES FOUND NO ISSUES OR DISCREPANCIES, WHICH COULD RELATE TO THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT, AS THE COMPLAINT MAY BE DUE TO CONTACT BETWEEN THE BALLOON AND A SHARP EXTERIOR SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 3005099803-2008-05311, -05312. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THREE EXTRACTOR RX BALLOONS RUPTURED. A 15-18MM EXTRACTOR RETRIEVAL BALLOON RUPTURED, WHILE GOING THROUGH THE PAPILLA. A SECOND 15-18MM EXTRACTOR RETRIEVAL BALLOON WAS ATTEMPTED AND ALSO RUPTURED. A SMALLER 12-15MM BALLOON WAS THEN ATTEMPTED AND ALSO RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH BALLOON OF THE 12-15MM SIZE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, AS A RESULT OF THESE EVENTS AND THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE - BILIARY STONE RETRIEVAL BALLOON CATHETER FGE BOSTON SCIENTIFIC CORK LTD. M00546920 11953942

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR