BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME

    MDR report key: 21294705 · Received February 3, 2025

    Report

    Report Number
    3005099803-2025-00180
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 10, 2025
    Report Date
    March 19, 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 EVENT 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 BLACKENED, WHICH INDICATES THAT THE DEVICE WAS ENERGIZED AND ABLE TO CONDUCT, ALSO, THE CUTTING WIRE WAS KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. THE ELECTRICAL TEST CANNOT BE PERFORMED DUE TO THE DEVICE CONDITION. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF CUTTING WIRE BREAK WAS CONFIRMED. THE RESULTS OF THE ANALYSIS PERFORMED ON THE RETURNED DEVICE FOUND THAT THE CUTTING WIRE WAS KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. THE BREAK IN THE CUTTING WIRE COULD HAVE BEEN GENERATED IF THERE WAS CONTACT BETWEEN THE DEVICE AND THE SCOPE DURING ENERGIZATION OR IF THE DEVICE EXCEEDED THE MAXIMUM OF VOLTAGE DURING PROCEDURE. ALSO, ENERGIZING THE DEVICE PRIOR TO PERFORMING SPHINCTEROTOMY CAN COMPROMISE THE CUTTING WIRES INTEGRITY, CAUSING PREMATURE CUTTING WIRE FATIGUE. ONCE THE CUTTING WIRE BREAKS, ANY ATTEMPT TO REMOVE THE DEVICE FROM THE SCOPE CAN BEND THE CUTTING WIRE AS OBSERVED IN THE PRODUCT ANALYSIS. THE INVESTIGATION FINDINGS AND ALL INFORMATION AVAILABLE CONCLUDES THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE. 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

    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 EVENT OF CUTTING WIRE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PERFORMING ENDOSCOPIC SPHINCTEROTOMY (EST), CURRENT WAS APPLIED ON THE FIRST ATTEMPT AND EST COULD BE PERFORMED, BUT WHEN CURRENT WAS APPLIED DURING THE SECOND ATTEMPT, THE CURRENT WAS NOT GENERATED, AND IT WAS NOT POSSIBLE TO CUT. IT WAS REPORTED THAT THE WIRE BROKE BECAUSE THE PATIENT MOVED. A NEW STONETOME WAS UNPACKED, AND A BALLOON AND A BASKET WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO PROBLEM WITH THE PATIENT'S VITAL SIGNS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PERFORMING ENDOSCOPIC SPHINCTEROTOMY (EST), CURRENT WAS APPLIED ON THE FIRST ATTEMPT AND EST COULD BE PERFORMED, BUT WHEN CURRENT WAS APPLIED DURING THE SECOND ATTEMPT, THE CURRENT WAS NOT GENERATED, AND IT WAS NOT POSSIBLE TO CUT. IT WAS REPORTED THAT THE WIRE BROKE BECAUSE THE PATIENT MOVED. A NEW STONETOME WAS UNPACKED, AND A BALLOON AND A BASKET WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO PROBLEM WITH THE PATIENT'S VITAL SIGNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294975 STONETOME DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC CORPORATION M00535110 0034990868 08714729146599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown