BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1153352 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04339
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALCULI REMOVAL PROCEDURE THE RX LITHOTRIPTER BASKET DID NOT CRUSH THE CALCULI AND THE BASKET TIP WOULD NOT DISENGAGE. THE BASKET WAS ADVANCED TO THE BILIARY DUCT. THE CALCULI WERE CAPTURED IN THE BASKET AND AN ATTEMPT WAS MADE TO CRUSH THE CALCULI. CRUSHING WAS NOT EFFECTIVE AND THE BASKET TIP DID NOT DISENGAGE TO RELEASE THE CALCULI. THE DEVICE WAS REMOVED IN A PARTIALLY DEPLOYED STATE BY CUTTING THE WIRE FOLLOWING TWO HOURS OF EFFORTS TO REMOVE THE DEVICE. THE DEVICE WAS REMOVED IN MULTIPLE PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S LITHOTRIPTER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC - LITHROTRIPSY BAKSET LQC BOSTON SCIENTIFIC CORPORATION M00510890 11696962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention