BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIVEVAL BALLOON

    MDR report key: 1171348 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04639
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 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
    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE 8.5MM EXTRACTOR XL WAS INSERTED INTO COMMON BILE DUCT. AIR WAS INJECTED, HOWEVER THE BALLOON DID NOT INFLATE. ANOTHER EXTRACTOR XL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1