BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE

    MDR report key: 11855632 · Received May 20, 2021

    Report

    Report Number
    3005099803-2021-02247
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    February 24, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    UDI-DI
    08714729430223
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL WAS PARTIALLY EXPOSED AND TANGLED. THEREFORE, THE REPORTED EVENT OF COIL FAILED TO CLOSE IS CONFIRMED SINCE THE TANGLED COIL WOULD CAUSE DIFFICULTY MOVING THE OUTER SHEATH. THE DEVICE WAS ABLE TO BE UNTANGLED AND SHEATHED FULLY. SOME PEELING WAS NOTED ON THE COATING OF THE COIL, AND THE TIP OF THE BLUE OUTER SHEATH APPEARED STRETCHED. THE DAMAGE IS CONSISTENT WITH FORCE APPLIED WHILE ATTEMPTING TO SHEATH THE COIL. ADDITIONALLY, SCORCHING WAS NOTED ON THE SHEATH WHICH IS CONSISTENT WITH LASER DAMAGE. BASED ON ALL AVAILABLE INFORMATION, IT IS LIKELY THAT THE USER EXPERIENCED DIFFICULTY DURING THE PROCEDURE DUE TO THE COIL TANGLED. THE DAMAGE IS CONSISTENT WITH FORCE APPLIED WHILE ATTEMPTING TO SHEATH THE COIL. ADDITIONALLY, THERE IS EVIDENCE OF LASER DAMAGE ON THE SHEATH. 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 CAUSED OR CONTRIBUTED TO EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.

    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 LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE COIL WAS UNABLE TO STRAIGHTEN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE INVESTIGATION RESULTS REVEALED THE COIL/CONE PEELED/SHEARED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755430 STONE CONE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903200 0004873027 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1