BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH

    MDR report key: 16204392 · Received January 19, 2023

    Report

    Report Number
    9612126-2023-00001
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 19, 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 DURING THE OPERATION, 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 OF "D. SUSPECT MEDICAL DEVICE" IN THIS REPORT. LOT#:22I3083.

    Description of Event or Problem · 0

    ON (B)(6), 2022, AT A HOSPITAL IN JAPAN, IT WAS REPORTED THAT THE SUPER SHEATH WAS FRACTURED DURING A PROCEDURE. IT IS POSSIBLE THAT THE FRACTURED PORTION FELL OUT WHEN THE SHEATH AND DEVICE WERE REMOVED FROM THE PATIENT'S BODY AFTER SURGERY, SINCE THE PRESENCE OF THE FRACTURED PORTION WAS NOT CONFIRMED IN THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155385 SUPER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS THETERIZATION DRE TOGO MEDIKIT CO., LTD. 22I3083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention