BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    MDR report key: 1172177 · Received September 18, 2008

    Report

    Report Number
    3005099803-2008-04655
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GCA
    PMA / PMN Number
    K931619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE BALLOON FAILED TO INFLATE. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). AN EXTRACTOR XL 8.5 MM BALLOON CATHETER HAD BEEN ADVANCED INTO THE PT, BUT WOULD NOT INFLATE, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON GCA BOSTON SCIENTIFIC M00550450 0011503922

    Patients

    Seq Age Sex Outcome Treatment
    1