BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX

    MDR report key: 16728085 · Received April 12, 2023

    Report

    Report Number
    3005099803-2023-01721
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    UDI-DI
    08714729296409
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER PHONE: (B)(6). BLOCK H6: IMPACT CODES HAS BEEN CORRECTED. BLOCK H6: IMDRF DEVICE CODE A0406 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF THE METAL ROD - METAL CATHETER DID NOT CLOSE WITH THE PLASTIC SLEEVE. BLOCK H10 VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE THAT THE SIDE CAR RX WAS PUSHED BACK. DIMENSIONAL INSPECTION WAS PERFORMED AND FOUND THAT THE EXPOSED METAL WAS OUT OF SPECIFICATION. THE REPORTED COMPLAINT IS CONFIRMED, BASED ON ALL AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE USER MANIPULATION AND/OR THE TECHNIQUE APPLIED DURING THE PROCEDURE AFFECTED THE SIDE CAR RX PUSH BACK. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: +011(490)61812963950. IMDRF DEVICE CODE A0406 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF THE METAL ROD - METAL CATHETER DID NOT CLOSE WITH THE PLASTIC SLEEVE.

    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 BASKET IN AN ATTEMPT TO CRUSH A STONE. THE TRAPEZOID WAS INSERTED INTO THE CBD AND FREELY PASSED THROUGH IT. HOWEVER, THE METAL ROD - METAL CATHETER DID NOT CLOSE WITH THE PLASTIC SLEEVE, AS SEEN ON THE MONITOR. THE TRAPEZOID BASKET WAS REMOVED FROM THE DUODENOSCOPE. SEVERAL ATTEMPTS WERE MADE TO OPEN AND CLOSE IT, BUT THE DISTANCE BETWEEN THE METAL CATHETER AND THE PLASTIC SLEEVE REMAINED. THE PROCEDURE WAS COMPLETED WITH AN EXTRACTION BALLOON. THERE WAS NO PATIENT COMPLICATION 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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A TRAPEZOID WAS INSERTED INTO THE CBD AND FREELY PASSED THROUGH IT. HOWEVER, THE METAL ROD - METAL CATHETER DID NOT CLOSE WITH THE PLASTIC SLEEVE, AS SEEN ON THE MONITOR. THE TRAPEZOID BASKET WAS REMOVED FROM THE DUODENOSCOPE. SEVERAL ATTEMPTS WERE MADE TO OPEN AND CLOSE IT, BUT THE DISTANCE BETWEEN THE METAL CATHETER AND THE PLASTIC SLEEVE REMAINED. THE PROCEDURE WAS COMPLETED WITH AN EXTRACTION BALLOON. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137646 TRAPEZOID RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC CORPORATION M00510890 0030442149 08714729296409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown