BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1203541 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05292
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE IN THE BILE DUCT, THE DISTAL SHEATH OF THE LITHOTRIPTER COMPATIBLE BASKET BECAME TORN. IT IS UNK HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT WAS REPORTED TO BE "GOOD" POST PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC - LITHOTRIPSY BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510880

    Patients

    Seq Age Sex Outcome Treatment
    1