BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    MDR report key: 1171324 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04627
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 22, 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 A BILIARY STONE RETRIEVAL PROCEDURE, THE BALLOON FAILED TO INFLATE. THE TARGET STONE WAS IN THE COMMON BILE DUCT (CDB). AN EXTRACTOR XL 15MM BALLOON HAD BEEN ADVANCED THROUGH AN UNSPECIFIED TYPE OF SCOPE, OVER A JAGWIRE GUIDE WIRE, TO THE TARGET LESION. THE DEVICE WAS NOT "CHECKED" PRIOR TO USE. THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'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 11462541

    Patients

    Seq Age Sex Outcome Treatment
    1