BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX

    MDR report key: 23425736 · Received October 30, 2025

    Report

    Report Number
    3005099803-2025-05692
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 8, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296409
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF HANDLE CANNULA BREAK IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE IMDRF DEVICE CODE A23 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO CRUSH STONE IMDRF IMPACT CODE F2301 CAPTURES THE EVENT OF ADDITIONAL DEVICE REQUIRED TO FRAGMENT THE STONES AND REMOVED THE BASKET.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF HANDLE CANNULA BREAK. IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF DEVICE CODE A23 CAPTURES THE REPORTABLE EVENT OF BASKET FAILURE TO CRUSH STONE. IMDRF IMPACT CODE F2301 CAPTURES THE EVENT OF ADDITIONAL DEVICE REQUIRED TO FRAGMENT THE STONES AND REMOVED THE BASKET. BLOCK H11: THE RETURNED TRAPEZOID RX WAS ANALYZED, AND PRODUCT ANALYSIS FOUND THE WIRE DETACHED FROM THE HANDLE AND UNDER MICROSCOPE INSPECTION IT WAS OBSERVED BROKEN. THE SIDE CAR RX WAS OBSERVED TORN AND PUSH BACK 2.62 MM, AND THE SHEATH WAS OBSERVED STRETCHED. THE HANDLE CANNULA WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, THE MOST PROBABLE CAUSE OF THIS INVESTIGATION IS "CAUSE NOT ESTABLISHED", BECAUSE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. ON THE OTHER HAND, THE EVENTS OF "SIDE CAR RX PUSH BACK", "SIDE CAR RX TORN" AND "SYSTEM DAMAGED" WILL BE CLASSIFIED AS "ADVERSE EVENT RELATED TO PROCEDURE" BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENTS. IT IS NOT POSSIBLE TO DETERMINE WHETHER THE HANDLE CANNULA HAD ANY DAMAGE OR MANUFACTURING DEFECT THAT COULD HAVE AFFECTED THE PROCEDURE SINCE IT WAS NOT RETURNED. THE WIRE WAS RETURNED DETACHED; THIS MAY HAVE RESULTED FROM THE DIFFICULTIES ENCOUNTERED WHILE ATTEMPTING TO CRUSH THE STONE, FROM EXCESSIVE FORCE, OR FROM MANIPULATION. ADDITIONALLY, THE TIP WAS RETURNED ATTACHED TO THE BASKET; HOWEVER, IT IS DIFFICULT TO DETERMINE WHETHER THE WIRE BROKE, OR THE HANDLE CANNULA DETACHED BEFORE THE TIP COULD BE RELEASED. FOR THE EVENT OF ADDITIONAL DEVICE REQUIRED, IT HAPPENED DURING THE PROCEDURE, AND THE MOST PROBABLE CAUSE OF THIS REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ON THE OTHER HAND, THE DEVICE'S SIDE CAR WAS PUSH BACK. THIS WAS MOST LIKELY DUE TO THE AMOUNT OF FORCE APPLIED TO THE HANDLE WHEN TRYING TO DESTROY THE STONE. AND BY THIS FORCE APPLIED, THE WORKING LENGTH TENDS TO "RETRACT" ITSELF AND THEREFORE, PUSHING BACK THE SIDE CAR RX. ALSO, THE SAME FORCE APPLIED WHEN TRYING TO DESTROY THE STONE OR THE TECHNIQUE USED BY THE PHYSICIAN WHEN USING THE DEVICE COULD HAVE GOTTEN THE SIDE CAR RX TO GET TORN AND THE SHEATH TO STRETCHED DURING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO CRUSH A 2CM STONE IN THE COMMON BILE DUCT. HOWEVER, THE HANDLE CANNULA OF THE TRAPEZOID RX BROKE WHEN ATTEMPTING TO CRUSH THE STONE. THE BASKET WAS STUCK IN THE COMMON BILE DUCT. THE DOCTOR USED A SPYSCOPE WITH AN EHL PROBE TO FRAGMENT THE STONES AND THEN REMOVED THE BASKET USING A RATH TOOTH TOOL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ALLIANCE HANDLE WAS USED WITH THE TRAPEZOID RX TO ATTEMPT TO CRUSH A 2CM STONE IN THE COMMON BILE DUCT. HOWEVER, THE HANDLE CANNULA OF THE TRAPEZOID RX BROKE WHEN ATTEMPTING TO CRUSH THE STONE. THE BASKET WAS STUCK IN THE COMMON BILE DUCT. THE DOCTOR USED A SPYSCOPE WITH AN EHL PROBE TO FRAGMENT THE STONES AND THEN REMOVED THE BASKET USING A RATH TOOTH TOOL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618141 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510890 0035766219 08714729296409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention