BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 9962551 · Received April 15, 2020

    Report

    Report Number
    9612126-2020-00007
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 15, 2020
    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
    NURSE

    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 THE SAME LOT. DURING THE EXAMINATION OF THE RETURNED DEVICE, THE FRACTURED PART OF THE SHEATH (10MM FROM THE HUB OF THE SHEATH) WAS INSPECTED UNDER MAGNIFICATION, AND A CUT WAS FOUND THERE WHICH MAY HAVE BEEN CREATED BY CONTACT WITH A SHARP EDGE. THEREFORE, THE FURTHER INVESTIGATION WAS CONDUCTED ON THE MANUFACTURING PROCESS OF THE SHEATH, AND IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING PROCESSES WHERE A TOOL/EQUIPMENT WITH A SHARP EDGE WAS USED, AND THERE WERE NO MANUFACTURING RECORDS OF VISUAL INSPECTIONS OF THE SAME LOT WHICH SHOWED CUTS OR SCARS ON THE SHEATHS. JUDGING FROM THIS EXAMINATION, A POSSIBLE CAUSE OF THIS FRACTURE COULD BE THAT A SHARP EDGE SUCH AS AN ANESTHETIZING NEEDLE CAME INTO CONTACT WITH THE SHEATH DURING THE PROCEDURE WHICH RESULTED IN A DECREASE IN ITS TENSILE STRENGTH TO A POINT WHERE THE SHEATH COULD NOT WITHSTAND THE PULL FORCE DURING THE REMOVAL FROM THE PATIENT'S BODY. 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) 2020, 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
    424926 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. 19J17CL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention