BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERSHEATH

    MDR report key: 6165447 · Received December 11, 2016

    Report

    Report Number
    9612126-2016-00005
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Date of Event
    April 22, 2016
    Report Date
    May 20, 2016
    Manufacturer
    TOGO MEDIKIT CO. LTD.
    Product Code
    DRE
    PMA / PMN Number
    K141070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRACTURED PORTION OF SHEATH WAS INSPECTED UNDER MAGNIFICATION, AND A CUT WAS OBSERVED 40 MM FROM THE SHEATH TIP WHICH MAY HAVE BEEN CREATED DUE TO CONTACT WITH A SHARP EDGE. THE MANUFACTURING PROCESS WAS REVIEWED AND IT WAS DETERMINED THAT A FRACTURE SUCH AS THAT OBSERVED IS NOT POSSIBLE TO OCCUR AS A RESULT OF THE MANUFACTURING PROCESS SINCE NO SHARPS ARE USED DURING THE MANUFACTURING PROCESS. THEREFORE A POSSIBLE CAUSE IS THAT A SHARP OBJECT SUCH AS AN ANESTHETIZING NEEDLE CAME INTO CONTACT WITH THE SHEATH WHICH RESULTED IN A DECREASE IN ITS TENSILE STRENGTH AND IT FRACTURED AT THE POINT OF THE CUT WHEN THE SHEATH WAS PULLED OUT. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN (B)(4) . 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) 2016 AT THE (B)(6) IN (B)(6) IT WAS REPORTED THAT WHEN THE SUPERSHEATH DEVICE WAS PULLED OUT, IT WAS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815817 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1