BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERSHEATH

    MDR report key: 6483146 · Received April 11, 2017

    Report

    Report Number
    9612126-2017-00002
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 13, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRACTURED PART OF THE SHEATH (20 MM FROM THE HUB OF THE SHEATH) WAS INSPECTED UNDER MAGNIFICATION, AND A CUT WAS FOUND THERE WHICH MAY HAVE BEEN CREATED BY CONTACT WITH A SHARP EDGE. DURING THE INVESTIGATION, IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING PROCESSES WHERE A TOOL/EQUIPMENT WITH A SHARP EDGE WAS USED, AND THERE WERE NO MANUFACTURING RECORDS OF VISUAL INSPECTIONS WHICH SHOWED CUTS OR SCARS ON THE SHEATHS. THEREFORE, A POSSIBLE CAUSE OF THIS FRACTURE COULD BE THAT A SHARP EDGE SUCH AS AN ANESTHETIZING NEEDLE CAME INTO CONTACT WITH THE SHEATH DURING THE PROCEDURE WHICH RESULTED IN A DECREASE IN ITS TENSILE STRENGTH TO A POINT WHERE THE SHEATH COULD NOT WITHSTAND THE PULL FORCE DURING THE REMOVAL FROM THE PATIENT'S BODY. 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 SUSPECT MEDICAL DEVICE" IN THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 AT THE (B)(6) HOSPITAL IN (B)(6) IT WAS REPORTED THAT THE SUPERSHEATH DEVICE BROKE WHEN BEING PULLED OUT OF THE PATIENT'S BODY DURING A PROCEDURE. THE BROKEN PORTION OF THE SHEATH REMAINED IN THE PATIENT'S BODY AND WAS LATER SURGICALLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264217 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. 16J2785

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention