BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONETOME

    MDR report key: 21417344 · Received February 19, 2025

    Report

    Report Number
    3005099803-2025-00458
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 24, 2025
    Report Date
    March 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQR
    UDI-DI
    08714729146599
    PMA / PMN Number
    K191789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: THIS EVENT WAS REPORTED BY THE BOSTON SCIENTIFIC CORPORATION (BSC) SALES REPRESENTATIVE. THE HEALTHCARE FACILITY IS: (B)(6). 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 H2 (ADDITIONAL INFORMATION): BLOCK B5 (DESCRIBE EVENT OR PROBLEM) HAS BEEN UPDATED. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BREAK.

    Additional Manufacturer Narrative · 0

    BLOCK E1: THIS EVENT WAS REPORTED BY THE BOSTON SCIENTIFIC CORPORATION (BSC) SALES REPRESENTATIVE. THE HEALTHCARE FACILITY IS: (B)(6). PHONE NUMBER: (B)(6) FAX NUMBER: (B)(6) 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 USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE (CUTTING WIRE) WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 21, 2025*** IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. IT WAS REPORTED THAT THE TYPE OF PROCEDURE PERFORMED WAS ENDOSCOPIC SPHINCTEROTOMY (EST) AND THE ANATOMY LOCATION WAS PAPILLA OF VATER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE (CUTTING WIRE) WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360089 STONETOME DISLODGER, STONE, BILIARY LQR BOSTON SCIENTIFIC CORPORATION M00535110 0034990868 08714729146599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown