BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 16632427 · Received March 28, 2023

    Report

    Report Number
    3005099803-2023-01622
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296409
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE. BLOCK H10: THE RETURNED TRAPEZOID RX BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE SIDECAR RX WAS PUSHED BACK OUT OF SPECIFICATION. DIMENSIONAL INSPECTION OBSERVED THE SIDE CAR RX WAS PUSHED BACK APPROXIMATELY 3 MM WHICH IS OUT OF SPECIFICATION. FUNCTIONAL INSPECTION WAS PERFORMED, AND THE BASKET CAME OUT AND RETRACTED WITHOUT PROBLEMS. THEREFORE, THE REPORTED COMPLAINT OF "TIP FAILURE TO SEPARATE" IS NOT CONFIRMED. THE REPORTED EVENT WAS NOT CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE MANIPULATION OR TECHNIQUE APPLIED DURING THE PROCEDURE MAY HAVE CAUSED THE SIDE CAR RX BEING PUSHED BACK. THEREFORE, THIS ISSUE WILL BE DOCUMENTED AS AN UNREPORTED ALLEGATION, AND THE ASSIGNED CAUSE CODE IS "ADVERSE EVENT RELATED TO PROCEDURE."

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT OF TIP FAILURE TO SEPARATE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, AN ALLIANCE II HANDLE WAS USED IN CONJUNCTION WITH THE TRAPEZOID BASKET TO CRUSH A STONE. HOWEVER, THE TIP DID NOT SEPARATE FROM THE BASKET, TRAPPING THE STONE. WITH THE STONE STILL INSIDE THE BASKET, THE PHYSICIAN SHOOK THE BASKET UNTIL THE STONE WAS RELEASED. THE PROCEDURE WAS COMPLETED USING A SPYGLASS AND A LASER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX BASKET WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, AN ALLIANCE II HANDLE WAS USED IN CONJUNCTION WITH THE TRAPEZOID BASKET TO CRUSH A STONE. HOWEVER, THE TIP DID NOT SEPARATE FROM THE BASKET, TRAPPING THE STONE. WITH THE STONE STILL INSIDE THE BASKET, THE PHYSICIAN SHOOK THE BASKET UNTIL THE STONE WAS RELEASED. THE PROCEDURE WAS COMPLETED USING A SPYGLASS AND A LASER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713308 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510890 0026021267 08714729296409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown