BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    MDR report key: 1230996 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05545
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GCA
    PMA / PMN Number
    K931619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED ENDOSCOPIC PROCEDURE BALLOON DEFLATION DIFFICULTIES OCCURRED. AN EXTRACTOR XL 15MM RETRIEVAL BALLOON CATHETER HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION WITHIN THE BILE DUCT. WHEN ATTEMPTING TO INFLATE THE DEVICE, "NOT PROPER DILATATION" WAS NOTICED. IT ALSO APPEARED THAT THE BALLOON DID NOT FULLY DEFLATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON GCA BOSTON SCIENTIFIC M00550470 11767557

    Patients

    Seq Age Sex Outcome Treatment
    1