BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 3161758 · Received June 11, 2013

    Report

    Report Number
    3005099803-2013-05108
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF BASKET WIRE 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 RX LITHOTRIPTER COMPATABLE BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS CHECKED PRIOR TO USE AND THERE WAS NO VISIBLE DAMAGE TO THE DEVICE OR THE PACKAGING. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSIDE THE PATIENT, WHEN THE HANDLE OF THE DEVICE WAS ACTUATED, THE BASKET BROKE. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX LITHOTRIPTER COMPATABLE BASKET. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262798 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880

    Patients

    Seq Age Sex Outcome Treatment
    1