BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1040831 · Received May 9, 2008

    Report

    Report Number
    3005099803-2008-00448
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS FOR THIS LOT. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. THE MARCH 2008 15-MONTH LITHOTRIPTER BASKET PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. REGARDING THE PREMATURE TIP DETACHMENT, THE FOLLOWING IS AN EXCERPT FROM THE PRODUCT DIRECTIONS FOR USE: "IMPORTANT: IN THE EVENT THE BILIARY CALCULI CANNOT BE CRUSHED, THE TRAPEZOID RX HAS BEEN DESIGNED FOR THE BASKET TIP TO DISENGAGE MINIMIZING THE POTENTIAL FOR STONE ENTRAPMENT IN THE BASKET. IN THE EVENT, THIS SITUATION OCCURS, RETRIEVE THE BASKET TIP WITH GRASPING FORCEPS, OR ANOTHER APPROPRIATE RETRIEVAL DEVICE."

    Description of Event or Problem · 1

    A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE IN A MALE PATIENT (AGE, AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, "[D] URING THE PROCEDURE, THE BASKET BROKE [TIP DETACHED] TOO EARLY." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE AND THE PATIENT 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 M00510890 9681226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK