BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 14576911 · Received June 2, 2022

    Report

    Report Number
    9612126-2022-00008
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 2, 2022
    Manufacturer
    TOGO MEDIKIT CO., LTD.
    Product Code
    DRE
    PMA / PMN Number
    K200379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL PRODUCT OF THE EVENT WAS RETURNED THIS TIME. AS A RESULT OF THE INSPECTION OF THE RETURNED EQUIPMENT, THE BROKEN PART OF THE SHEATH WAS ENLARGED AND INVESTIGATED, AND IT WAS CONFIRMED THAT THE RESIN OF THE SHEATH TUBE WAS MELTED AND BROKEN. JUDGING FROM HEARING SURVEYS BY MEDICAL INSTITUTIONS, THE CAUSE OF THIS BREAKAGE WAS THAT THE SHEATH TUBE MELTED DUE TO ABLATION DUE TO ACCIDENTAL LASER IRRADIATION IN THE SHEATH TUBE WHILE USING A LASER TREATMENT DEVICE FOR LOWER LIMB VARICOSE VEINS FOR THE TREATMENT OF LOWER LIMB VARICOSE VEINS. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN (B)(6). THEREFORE, THE INFORMATION ON THE EQUIVALENT DEVICE TO THE COMPLAINT DEVICE THAT WAS CLEARED UNDER K141070 IS FILLED. LOT#: 22C1434.

    Description of Event or Problem · 0

    ON (B)(6) 2022, AT A HOSPITAL IN (B)(6), IT WAS REPORTED THAT THE SUPER SHEATH WAS FRACTURED DURING A PROCEDURE. THE FRACTURED PORTION REMAINED IN THE PATIENT'S BODY AND WAS REMOVED APPROPRIATELY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227679 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS THETERIZATION DRE TOGO MEDIKIT CO., LTD. 22C1434

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention