BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1191870 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04955
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #3005099803-2008-04954. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE BASKET WOULD NOT OPEN. THE TARGET STONES WERE IN THE COMMON BILE DUCT. A HYDRATOME RX 44-20MM/260 CM HAD BEEN SELECTED FOR USE. PRIOR TO INSERTION INTO AN UNSPECIFIED TYPE OF SCOPE, IT WAS NOTICED THAT THE DEVICE DID NOT HAVE A CAUTERY PORT. ANOTHER OF THE SAME DEVICE WAS USED TO GAIN ACCESS TO THE DUCT. THE PHYSICIAN THEN SELECTED AN RX LITHOTRIPTER BASKET AND TESTED THE DEVICE TO ENSURE THAT THE BASKET WOULD OPEN. AFTER PASSING THE PHYSICIAN'S TEST, THE DEVICE WAS ADVANCED TO THE TARGET STONES BUT THE DEVICE WOULD NOT OPEN INSIDE THE DUCT. THE RX LITHOTRIPTER BASKET WAS EXCHANGED FOR ANOTHER OF THE SAME DEVICE AND THE IDENTICAL PROBLEM OCCURRED. THE TARGET STONES WERE ABLE TO BE REMOVED WITH A 3RD RX LITHOTRIPTER BASKET. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF AN UNSPECIFIED STENT. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION AS "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR