BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 3182199 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05176
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF HANDLE BREAK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, A STONE WAS CAPTURED WITH THE LITHOTRIPTER BASKET WITHIN THE COMMON BILE DUCT. THE PHYSICIAN NOTED THAT THE STONE WAS TOO RIGID TO BE CRUSHED. THE ALLIANCE HANDLE WAS THEN USED IN CONJUNCTION WITH THE BASKET AND LITHOTRIPSY WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN REPOSITIONED THE BASKET THEN ATTEMPTED LITHOTRIPSY ON A SECOND STONE, HOWEVER THE CABLE IN THE BASKET HANDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282124 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 15711218

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR