BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1234047 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05941
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND 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 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. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT: 3005099803-2008-05940. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE COMMON BILE DUCT (CBD). THE EXTRACTOR RX 9MM X 12MM RETRIEVAL BALLOON WAS ADVANCED TO THE LESION, HOWEVER, AT AN UNSPECIFIED TIME DURING THE PROCEDURE THE BALLOON FAILED TO DEFLATE. IT WAS NOT KNOWN HOW THE DEVICE WAS REMOVED. A SECOND OF THE SAME DEVICE WAS ADVANCED TO THE LESION, HOWEVER, THIS BALLOON ALSO FAILED TO DEFLATE AND IT WAS NOT KNOWN HOW THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "FINE".

    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 M00546900 11977923

    Patients

    Seq Age Sex Outcome Treatment
    1