BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 9693130 · Received February 11, 2020

    Report

    Report Number
    9612126-2020-00003
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 11, 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 ACTUAL ITEM OF THIS EVENT WAS NOT RETURNED. WHEN A REPRODUCIBILITY TEST WAS PERFORMED USING THE SAME TYPE OF PRODUCT HAVING THE SAME SPECIFICATIONS AS THE PRODUCT IN QUESTION, IT WAS CONFIRMED THAT THE TENSILE STRENGTH SATISFIED THE STANDARD. A SIMILAR EVENT HAS OCCURRED IN THIS MEDICAL INSTITUTION IN THE PAST, AND AS A RESULT OF INSPECTION OF THE DEVICE RETURNED AT THAT TIME, A FRACTURE DAMAGE DUE TO CONTACTING WITH A SHARP BLADE OR THE LIKE WAS OBSERVED AT THE BROKEN PORTION OF THE SHEATH. THEREFORE, IT IS CONSIDERED THAT THE CAUSE OF THIS BREAKAGE WAS THAT A SHARP BLADE OR THE LIKE CAME INTO CONTACT DURING THE PROCEDURE, THE STRENGTH WAS REDUCED, AND THE SHEATH WAS BROKEN BY THE FORCE TO PULL OUT THE SHEATH. 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
    156560 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention