BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1213961 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05529
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO 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, THE BALLOON POPPED AND THE TIP DISLODGED INSIDE THE PT. AN EXTRACTOR RX 15-18 MM BALLOON CATHETER HAD BEEN ADVANCED TO RETRIEVE STONES IN THE BILIARY DUCT. WHILE REMOVING STONES THROUGH THE PAPILLA, THE STONE CAME OUT, THE BALLOON POPPED AND THE TIP OF THE BALLOON CATHETER DISLODGED INSIDE THE PT'S SMALL BOWEL. THE DISLODGED PIECE WAS LEFT INSIDE THE PT TO BE PASSED "NATURALLY". THE PROCEDURE WAS CONSIDERED TO BE COMPLETE USING THIS DEVICE. THERE WERE NO ADD'L PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546920 11579691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other