BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    MDR report key: 1234050 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05922
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GCA
    PMA / PMN Number
    K931619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE "BILIARY SYSTEM". THE EXTRACTOR XL 11.5MM RETRIEVAL BALLOON WAS ADVANCED, HOWEVER, AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE "BALLOON POPPED" ON AN UNSPECIFIED INFLATION AT UNSPECIFIED ATMS. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON GCA BOSTON SCIENTIFIC CORPORATION M00550460 11442684

    Patients

    Seq Age Sex Outcome Treatment
    1