BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERSHEATH

    MDR report key: 7775838 · Received August 12, 2018

    Report

    Report Number
    9612126-2018-00011
    Event Type
    Injury
    Date Received
    August 12, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 8, 2018
    Manufacturer
    TOGO MEDIKIT CO. LTD.
    Product Code
    DRE
    PMA / PMN Number
    K141070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS RETURNED. THE RETURNED DEVICE WAS EXAMINED, AND THE REPEATABILITY TEST. WAS CONDUCTED USING RESERVED SAMPLES WITH VOLUNTARY LOT NUMBERS THAT ARE THE SAME SPECIFICATION AS THE DEVICE INVOLVED IN THE EVENT. DURING THE EXAMINATION OF THE RETURNED DEVICE, A FRACTURED PORTION OF THE SHEATH WAS INSPECTED WITH MAGNIFICATION, AND A TRACE OF CUTTING WAS OBSERVED THAT SEEMED TO BE MADE BY SOMETHING LIKE SCISSORS. JUDGING FROM THIS EXAMINATION, A POSSIBLE CAUSE OF THIS FRACTURE IS THAT THE SHEATH WAS ACCIDENTALLY CUT BY SOMETHING LIKE SCISSORS DURING THE PROCEDURE. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN (B)(4). THEREFORE, THE INFORMATION ON THE EQUIVALENT DEVICE TO THE COMPLAINT DEVICE THAT WAS CLEARED UNDER K141070.

    Description of Event or Problem · 1

    ON (B)(6) 2018, 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 ADEQUATELY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616858 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention