BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 17759492 · Received September 15, 2023

    Report

    Report Number
    3005099803-2023-04851
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296393
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF HANDLE CANNULA BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE BASKET WOULD NOT OPEN. IT WAS ALSO NOTED THAT THE HANDLE CANNULA WAS BENT AFTER THE FIRST PASS. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294830 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510880 0030812421 08714729296393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown