BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    MDR report key: 2072997 · Received April 29, 2011

    Report

    Report Number
    3005099803-2011-01420
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SOLID WIRE WITHIN THE HANDLE BROKE WHILE USING THE ALLIANCE HANDLE TO CRUSH A STONE. AFTER THE WIRE BROKE THE HANDLE WAS REMOVED AND THE WIRE WAS ATTACHED TO A SOEHENDRA LITHOTRIPSY SYSTEM AND THE PHYSICIAN WAS ABLE TO 'POP' THE TIP OF THE BASKET AND REMOVE THE DEVICE FROM THE PATIENT. THE PANCREATIC STONE WAS APPROXIMATELY 1.6CM AND IT REMAINS WITHIN THE PATIENT ALONG WITH THE DETACHED DEVICE TIP. THE PROCEDURE LASTED 2-3 HOURS AND THE PATIENT SPENT ONE NIGHT IN THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT IS IN WELL CURRENT CONDITION AND WILL BE RESCHEDULED FOR A LASER LITHOTRIPSY AT A FUTURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510870 14181760

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O