BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 16587533 · Received March 21, 2023

    Report

    Report Number
    9612126-2023-00007
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 21, 2023
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL PRODUCT OF THE EVENT WAS RETURNED THIS TIME. THE RETURNED EQUIPMENT WAS INSPECTED AND THE REPEATABILITY TEST (TENSILE STRENGTH TESTING ETC.) WAS CONDUCTED USING THE SAME PRODUCT. AS SUCH, THE SHEATH'S MANUFACTURING PROCESS WAS INVESTIGATED TO DETERMINE THAT NONE OF THE MANUFACTURING PROCESSES HAD CAUSED OR CONTRIBUTED TO THIS EVENT, AND THERE WERE NO VISUAL INSPECTION RECORDS TO INDICATE THAT IT HAD CAUSED OR CONTRIBUTED TO THIS EVENT. JUDGING FROM THIS TEST, THE PROBABLE CAUSE OF THIS RUPTURE IS THOUGHT TO BE THAT THE SHEATH WAS REPEATEDLY SUBJECTED TO A LOAD EXCEEDING THE ALLOWABLE LEVEL WHILE COMPLETING SURGERY, RESULTING IN A DECREASE IN STRENGTH AND RUPTURE DUE TO THE FORCE WITH WHICH THE SHEATH WAS PULLED OUT. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN JAPAN. THEREFORE, THE INFORMATION ON THE EQUIVALENT DEVICE TO THE COMPLAINT DEVICE THAT WAS CLEARED UNDER K141070 IS FILLED IN §1, 2, AND 4. LOT#: UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2023, AT A HOSPITAL IN JAPAN, IT WAS REPORTED THAT THE SUPER SHEATH WAS FRACTURED DURING THE COMPLETION OF THE PROCEDURE. THE PATIENT CONFIRMED THAT A PORTION OF THE SHEATH HAD BEEN REMOVED FROM THE BODY AFTER THE RUPTURE, SO IT WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356566 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS THETERIZATION DRE TOGO MEDIKIT CO., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention