BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME

    MDR report key: 22348847 · Received June 27, 2025

    Report

    Report Number
    3005099803-2025-02853
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    February 28, 2025
    Report Date
    June 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQR
    UDI-DI
    08714729146599
    PMA / PMN Number
    K191789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K946358; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF CUTTING WIRE BREAK. BLOCK H11: INVESTIGATION RESULTS THE RETURNED STONETOME WAS ANALYZED, AND A VISUAL AND MICROSCOPIC INSPECTION FOUND THAT THE CUTTING WIRE WAS BROKEN AND NOT CRIMPED TO THE CONNECTOR JOINT STRENGTH AT THE HANDLE SECTION. AS A RESULT, DURING ATTEMPTS TO BOW, THE CUTTING WIRE DETACHED FROM THE WORKING LENGTH. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. DURING ANALYSIS OF THE RETURNED DEVICE, IT WAS DETERMINED THAT THE CUTTING WIRE DID NOT HAVE EVIDENCE OF CRIMPING AND WAS NOT CRIMPED TO THE CONNECTOR JOINT STRENGTH AT THE HANDLE SECTION DURING THE MANUFACTURING PROCESS. THE INVESTIGATION FINDINGS AND ALL INFORMATION AVAILABLE CONCLUDES THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING DEFICIENCY. A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION WAS COMPLETED BY BOSTON SCIENTIFIC CORPORATION (BSC) TO ADDRESS THIS PROBLEM. THE NCEP INVESTIGATION CONCLUDED THAT THE REFERENCED EVENT WAS AN ISOLATED EVENT DUE TO HUMAN ERROR DURING MANUFACTURING. A REVIEW OF THE MANUFACTURING PROCESS FOUND IT LIKELY THAT A STEP IN THE PROCEDURE WAS OMITTED. THE STEP IN WHICH THE OPERATOR ASSEMBLES THE CUTTING WIRE AND CONFIRMS IT IS PROPERLY POSITIONED WAS NOT PERFORMED CORRECTLY. ALL APPLICABLE PRODUCT BUILDERS WERE MADE AWARE OF THE EVENT AND THE PROCEDURE WAS REVIEWED BY ALL APPLICABLE PRODUCT BUILDERS TO HEIGHTEN AWARENESS OF THE REQUIREMENTS OUTLINED IN THIS MANUFACTURING PROCESS. AS PART OF THE NCEP INVESTIGATION, A RISK ASSESSMENT WAS PERFORMED. WIRE DETACHED/SEPARATED IS A KNOWN AND ANTICIPATED, POTENTIAL FAILURE MODE OUTLINED IN THE DEVICE RISK DOCUMENTATION, AND THE SEVERITY IS CONSIDERED MODERATE, WITH AN ANTICIPATED CLINICAL EFFECT OF PROLONGED PROCEDURE. THE RISK ASSESSMENT CONFIRMED THAT THE OBSERVED SEVERITY (HARM) AND OCCURRENCE RANKINGS ARE WITHIN WITH THE ANTICIPATED RISK LEVEL DOCUMENTED IN RISK DOCUMENTATION, AND THE RISK IS ACCEPTABLE. THE INVESTIGATION IS COMPLETE AND THE NCEP WAS CLOSED IN OCTOBER 2024. BSC WILL CONTINUE TO MONITOR AND TREND THESE COMPLAINTS AND ASSOCIATED RISKS AS OUTLINED IN OUR QUALITY SYSTEMS PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT A BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE DID NOT MOVE EVEN WHEN THE HANDLE WAS PUSHED AND PULLED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A CUTTING WIRE BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973268 STONETOME DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC CORPORATION M00535110 0034727841 08714729146599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown