BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1051678 · Received May 19, 2008

    Report

    Report Number
    3005099803-2008-00501
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES ASSOCIATED WITH THIS COMPLAINT WERE NOTED. THE 2008 15-MONTH LITHOTRIPTER BASKET PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE IN A MALE PATIENT IN 2008. ACCORDING TO THE COMPLAINANT, "THE BASKET WAS PASSED INTO THE COMMON BILE DUCT, BUT WHEN THE NURSE WENT TO CRUSH THE STONES BY HAND, THE TIP OF THE BASKET POPPED OFF." THE PHYSICIAN RETRIEVED THE BASKET AND COMPLETED THE PROCEDURE WITH A SECOND TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510870 11056664

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR