BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERSHEATH

    MDR report key: 7750913 · Received August 6, 2018

    Report

    Report Number
    9612126-2018-00009
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    June 26, 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 (TENSILE STRENGTH TESTING ETC.) WAS CONDUCTED USING RESERVED SAMPLES WITH THE SAME LOT NUMBER AS THAT INVOLVED IN THE EVENT. ALSO, THE INVESTIGATION WAS CONDUCTED BY REVIEWING THE RECORDS OF THE MANUFACTURING PROCESSES OF THE SHEATH WITH THE SAME LOT NUMBER AS THAT INVOLVED IN THE EVENT, AND IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING PROCESSES THAT CAUSED OR CONTRIBUTED TO THE EVENT, AND THERE WERE NO MANUFACTURING RECORDS OF VISUAL INSPECTIONS THAT SHOWED THE CAUSE OF OR CONTRIBUTION TO THE EVENT. JUDGING FROM THIS EXAMINATION, A POSSIBLE CAUSE OF THIS FRACTURE IS THAT A SHARP EDGE SUCH AS A KNIFE CAME INTO CONTACT WITH THE SHEATH DURING THE PROCEDURE. THIS RESULTED IN A DECREASE IN TENSILE STRENGTH OF THE SHEATH TO A POINT WHERE THE SHEATH COULD NOT WITHSTAND THE PULL FORCE AND FRACTURED. 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 IN §1, 2, AND 4 OF "D. SUSPECT MEDICAL DEVICE" IN THIS REPORT.

    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 WHEN IT WAS PULLED OUT OF A PATIENT'S BODY 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
    594467 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. 18E22CM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention