BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1111546 · Received August 13, 2008

    Report

    Report Number
    3005099803-2008-02182
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP), A BASKET BREAK OCCURRED. THE STONE WAS LOCATED IN THE COMMON BILE DUCT (CBD). THE RX LITHOTRIPTER COMPATABLE BASKET WAS ADVANCED TO THE CBD. AT AN UNSPECIFIED TIME, THE BASKET BROKE AND WAS "LODGED AROUND THE STONE". THE BASKET WAS UNABLE TO BE RETRIEVED. THE PHYSICIAN REMOVED THE BASKET'S CATHETER BY "CUTTING THE WIRES WITH A NEEDLE KNIFE". THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE A CHOLECYSTECTOMY WAS PERFORMED. THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention