BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX

    MDR report key: 9847434 · Received March 18, 2020

    Report

    Report Number
    3005099803-2020-00885
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296393
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, POST SPHINCTEROTOMY A STONE WAS UNABLE TO BE REMOVED DUE TO THE SIZE OF THE STONE. A LITHOTRIPTER BASKET WAS THEN USED IN AN ATTEMPT TO CRUSH THE STONE. THE STONE WAS UNABLE TO BE CRUSHED BY HAND WITH THE TRAPEZOID BASKET. THEREFORE AN ALLIANCE 2 HANDLE WAS USED IN CONJUNCTION WITH THE TRAPEZOID BASKET FOR MECHANICAL LITHOTRIPSY. HOWEVER, A BREAKING SOUND WAS HEARD BEFORE THE MAXIMUM TENSION WAS ACHIEVED. UPON REMOVAL OF THE TRAPEZOID FROM THE ALLIANCE 2 HANDLE, IT WAS NOTED THAT THE BREAK OCCURRED IN THE WIRE MECHANISM BETWEEN THE HANDLE AND THE BASKET. THE PHYSICIAN DECIDED TO USE THE EMERGENCY LITHOTRIPSY MECHANISM AVAILABLE (MEDWORKS) AND CUT THE TRAPEZOID BASKET BELOW THE HANDLE. THE OUTER METAL SHEATH ON THE TRAPEZOID COULD NOT BE REMOVED TO ALLOW THE INNER WIRES TO PASS THROUGH THE EMERGENCY LITHOTRIPSY MECHANISM. EMERGENCY LITHOTRIPSY WAS UNSUCCESSFUL SO THEY DECIDED TO LEAVE THE REMAINING TRAPEZOID INSIDE THE PATIENT AND TRANSFER THE PATIENT TO THE HEPATO-PANCREATICO-BILIARY (HPB) TEAM AT QUEENS MEDICAL CENTRE (QMC) IN NOTTINGHAM, ENGLAND. AT THIS POINT, THE PHYSICIAN USED THEIR EMERGENCY LITHOTRIPTER KIT (OLYMPUS) TO BREAK THE BASKET ENDOSCOPICALLY. THE BASKET WAS REMOVED FROM THE PATIENT. THE STONE WAS NOT REMOVED WITH THE BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. ANOTHER ERCP IS SCHEDULED AS THE PATIENT HAD SEVERAL STONES THAT REQUIRED REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313195 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION 1088 0023916528 08714729296393

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention