BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX

    MDR report key: 16959588 · Received May 19, 2023

    Report

    Report Number
    3005099803-2023-02596
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 26, 2023
    Report Date
    July 10, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE STONE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ANOTHER DEVICE WAS USED TO RESCUE THE SITUATION.

    Additional Manufacturer Narrative · 0

    BLOCK D4 (LOT NUMBER AND EXPIRATION DATE) AND H4 HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON JUNE 15, 2023. BLOCK H6: IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO RELEASE STONE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ANOTHER DEVICE WAS USED TO RESCUE THE SITUATION. BLOCK H10: THE RETURNED TRAPEZOID RX BASKET WAS ANALYZED, AND A VISUAL INSPECTION NOTED THAT THE HANDLE CANNULA WAS DETACHED AND WAS NOT RETURNED. THE WORKING LENGTH WAS DETACHED IN TWO PARTS. THE THUMB RING SHOWS STRESS MARKS. THE PROXIMAL SECTION OF THE SHEATH WAS TORN. THE PULL WIRE WAS SEPARATED FROM THE WORKING LENGTH, KINKED, AND DETACHED FROM THE CANNULA. THE TIP OF THE BASKET WAS DETACHED AND NOT RETURNED. THE DISTAL AND PROXIMAL SCREW DEPTH WERE MEASURED AND FOUND WITHIN SPECIFICATION. THE BASKET WAS RETURNED WITHOUT THE TIP, SUGGESTING THAT IT COULD BE RELEASED AS EXPECTED. THEREFORE, THE REPORTED EVENT OF TIP FAILURE TO SEPARATE AND BASKET FAILURE TO RELEASE STONE WAS NOT CONFIRMED. HOWEVER, THE DEVICE WAS RETURNED WITH MULTIPLE DAMAGES. BASED ON ALL AVAILABLE INFORMATION, IT IS MOST LIKELY THAT PROCEDURAL FACTORS AND HANDLING OF THE DEVICE AFFECTED ITS PERFORMANCE. THE STRESS MARKS ON THE THUMB RING ARE EVIDENCE OF OVER MANIPULATION. IT IS POSSIBLE THAT DUE TO THE SIZE OF THE STONE WHILE ATTEMPTING TO CRUSH IT COULD HAVE LED TO THE MARKS ON THE THUMB RING AND THE DAMAGED TO THE SHEATH. ADDITIONAL FORCE APPLIED TO THE DEVICE COULD HAVE ENDED DETACHING THE HANDLE CANNULA AND THE PULL WIRE, AND AS CONSEQUENCE KINKING IT. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE SINCE THE ADVERSE EVENT OCCURRED DURING PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED IN AN ATTEMPT TO CRUSH A STONE, HOWEVER, UPON TRYING TO CRUSH THE STONE, THE DEVICE FAILED TO BREAK, AND THE HANDLE FAILED TO OPEN AGAIN TO RELEASE THE STONE. ANOTHER DEVICE WAS USED TO RESCUE THE SITUATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN (B)(6) 2023. DURING THE PROCEDURE, A TRAPEZOID RX BASKET WAS USED IN AN ATTEMPT TO CRUSH A STONE, HOWEVER, UPON TRYING TO CRUSH THE STONE, THE DEVICE FAILED TO BREAK, AND THE HANDLE FAILED TO OPEN AGAIN TO RELEASE THE STONE. ANOTHER DEVICE WAS USED TO RESCUE THE SITUATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874096 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510880 0029422767 08714729296393

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention