BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE

    MDR report key: 11809934 · Received May 11, 2021

    Report

    Report Number
    3005099803-2021-02065
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    January 6, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGO
    UDI-DI
    08714729430223
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL WAS PARTIALLY EXPOSED AND KNOTTED. THE OUTER SHEATH WAS NOT ABLE TO EXTEND OVER THE TANGLED COIL TO CLOSE THE DEVICE. 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. BASED ON ALL AVAILABLE INFORMATION, SINCE THE DEVICE ARRIVED WITH THE COIL OPEN AND KNOTTED, IT IS MOST LIKELY THAT THE DIFFICULTY EXPERIENCED BY THE USER OCCURRED WHILE TESTING THE DEVICE PRIOR TO USE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS FOR TESTING THE DEVICE PRIOR TO USE AND STATES "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) 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 TO BE USED IN THE URETER DURING A URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS UNABLE TO RECAPTURE AND DEPLOY FREELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THE COIL COATING WAS PEELED. THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705720 STONE CONE DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC CORPORATION M0063903200 0004995771 08714729430223

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR