BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 12126118 · Received July 7, 2021

    Report

    Report Number
    9612126-2021-00005
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 7, 2021
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT OF THE EVENT WAS RETURNED. THE RETURNED EQUIPMENT WAS INSPECTED AND A REPRODUCIBILITY TEST WAS CONDUCTED USING RESERVED SAMPLES. DURING THE INSPECTION OF THE RETURNED EQUIPMENT, THE PART OF THE SHEATH THAT WAS BROKEN (10 CM FROM THE TIP OF THE SHEATH) WAS MAGNIFIED AND EXAMINED, AND THE BREAKAGE DAMAGE CAUSED BY CONTACT WITH A SHARP BLADE, ETC. WAS CONFIRMED. THEREFORE, THE MANUFACTURING PROCESS OF THE SHEATH WAS FURTHER CHECKED, AND IT WAS CONFIRMED THAT THERE WAS NO MANUFACTURING PROCESS USING SHARP KNIVES OR OTHER TOOLS, AND THAT THERE WAS NO MANUFACTURING TRACK RECORD OF VISUAL INSPECTION OF THE PRODUCT IN QUESTION, SINCE SCRATCHES, ETC. WERE CONFIRMED BY VISUAL INSPECTION OF THE SHEATH. JUDGING FROM THIS TEST, THE CAUSE OF THIS RUPTURE WAS THOUGHT TO BE CONTACT WITH A SHARP BLADE OR THE LIKE DURING THE PROCEDURE, WHICH REDUCED THE STRENGTH AND CAUSED THE SHEATH TO BREAK UNDER THE FORCE OF PULLING IT OUT. PLEASE REFER TO THE ATTACHED REPORT OF THE INVESTIGATION. 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) 2021, 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
    1025168 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention