BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE

    MDR report key: 12016003 · Received June 17, 2021

    Report

    Report Number
    3005099803-2021-02894
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    UDI-DI
    08714729430223
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL BREAK/FRACTURED. BLOCK H10: THE RETURNED STONE CONE WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE COIL WAS DETACHED AT THE DISTAL END OF THE WORKING LENGTH. THERE WERE BURN MARKS AND SIGNS OF LASER DAMAGE AT THE SPOT WHERE THE COIL WAS DETACHED. THE DETACHED COIL WAS RETURNED IN TWO PIECES AS THE LASER DAMAGE CAUSED A SMALL PIECE TO SEPARATE. THE REPORTED EVENT WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, THE ANALYZED CONDITION OF THE DEVICE PROVIDES CLEAR EVIDENCE THAT IT WAS FIRED UPON BY THE LASER. THE INSTRUCTIONS FOR USE (IFU) WARNS THE USER "DO NOT FIRE UPON THE DEVICE WITH A LASER." THEREFORE, THE MOST PROBABLE ROOT CAUSE IS UNINTENDED USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON MAY 24, 2021. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED DURING THE USE OF A LASER. ANOTHER STONE CONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DEVICE WAS FRACTURED DURING THE USE OF A LASER. ANOTHER STONE CONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912070 STONE CONE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903200 0005716805 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1