BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE

    MDR report key: 14220346 · Received April 27, 2022

    Report

    Report Number
    3005099803-2022-02354
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    January 12, 2022
    Report Date
    April 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    UDI-DI
    08714729430209
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS 1 : (B)(6). (B)(4). VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL WAS DETACHED AT THE DISTAL END. THE DETACHED COIL WAS RETURNED. SINCE THE TIP ALONG WITH DISTAL STOP IS DETACHED, THE SHEATH IS NOT ABLE TO BE CLOSED/OPENED AS INTENDED. ADDITIONALLY, A KINK WAS OBSERVED ON THE BLUE SHEATH. BASED ON ALL AVAILABLE INFORMATION, IT IS MOST LIKELY THE TIP DETACHMENT WAS CAUSED BY FIRING THE LASER ON THE DEVICE AND THE KINK WAS CAUSED DURING THE TEST OF THE DEVICE WITH THE USE OF EXCESSIVE FORCE OR MANIPULATION. THE INSTRUCTIONS FOR USE (IFU) STATES "DO NOT FIRE UPON THE DEVICE WITH A LASER" AND PRIOR TO USE, ENSURE THAT THE COIL IS WORKING PROPERLY BY ADVANCING THE SHEATH OVER THE COIL TO THE POSITIVE STOP AND THEN RETRACTING THE SHEATH TO OPEN THE COIL. THE SHEATH OF THE DEVICE SHOULD BE STRAIGHT DURING TESTING." THEREFORE, THE MOST PROBABLE ROOT CAUSE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION. A LABELING REVIEW WAS PERFORMED, AND THERE IS NO EVIDENCE THAT THE DEVICE WAS USED NOT IN ACCORDANCE WITH THE LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE FAILED TO CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THE COIL/CONE PEELED/SHEARED AND THE TIP SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479721 STONE CONE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903100 0005870607 08714729430209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown