BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 21918343 · Received April 28, 2025

    Report

    Report Number
    3005099803-2025-01752
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    July 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296379
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H2: ADDITIONAL INFORMATION BLOCK D4 (LOT NUMBER) AND BLOCK E1 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED. BLOCK H6: IMDRF IMPACT CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE IMDRF IMPACT CODE A23 CAPTURES THE REPORTABLE EVENT OF BASKET FAILED TO CRUSH STONE.

    Additional Manufacturer Narrative · 0

    BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. IMDRF IMPACT CODE A23 CAPTURES THE REPORTABLE EVENT OF BASKET FAILED TO CRUSH STONE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE IMDRF IMPACT CODE A23 CAPTURES THE REPORTABLE EVENT OF BASKET FAILED TO CRUSH STONE. BLOCK H11: A TRAPEZOID RX WAS RECEIVED FOR ANALYSIS. THE DEVICE RETURNED DISASSEMBLED, ONLY THE PULL WIRE WAS RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE PULL WIRE HAD EVIDENCE THAT IT WAS PREVIOUSLY ATTACHED TO THE HANDLE AND WAS ALSO KINKED. THE BASKET WIRES WERE KINKED. THE REPORTED EVENT BASKET FAILURE TO CRUSH STONE WAS NOT CONFIRMED, HOWEVER, THE REPORTED EVENT TIP FAILURE TO SEPARATE CAN BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICE COULD HAVE ALSO FAILED TO CRUSH THE STONE DUE TO THE DAMAGES SEEN IN THE DEVICE. IT IS MOST LIKELY THAT THE INTERACTION BETWEEN THE STONE AND THE BASKET ENDED UP GETTING THE BASKET WIRES KINKED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX WAS USED IN THE COMMON BILE DUCT DURING A FIBER CHOLEDOCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT STUNE COULDN'T BE CRUSHED, AND THE BASKET TIP COULDN'T BE DISENGAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO REPORTED 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 DURING A FIBER CHOLEDOCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT STONE COULDN'T BE CRUSHED, AND THE BASKET TIP COULDN'T BE DISENGAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO REPORTED 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 DURING A FIBER CHOLEDOCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT STUNE COULDN'T BE CRUSHED, AND THE BASKET TIP COULDN'T BE DISENGAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER TRAPEZOID RX. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757760 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510860 0034700334 08714729296379

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male