BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1102089 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01452
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS CATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT OF THE REPORTED EVENT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE STONES WERE LOCATED WITHIN AN UNSPECIFIED BILIARY DUCT. THE EXTRACTOR RX 9MM X 12MM RETRIEVAL BALLOON WAS ADVANCED TO THE DUCT. DURING AN UNSPECIFIED "SWEEP" OF THE DUCT WITH THE BALLOON INFLATED TO UNSPECIFIED ATMS, THE "BALLOON POPPED". THE BALLOON CATHETER WAS REMOVED INTACT. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE PRIOR TO THE BALLOON RUPTURE, THEREFORE, NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENTS STATUS IS REPORTED AS "FINE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546900 11717892

    Patients

    Seq Age Sex Outcome Treatment
    1