BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERSHEATH

    MDR report key: 6142031 · Received December 2, 2016

    Report

    Report Number
    9612126-2016-00003
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 4, 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 CUTTING WAS OBSERVED WHICH MAY HAVE BEEN CREATED DUE TO CONTACT WITH A SHARP EDGE. ALSO EXTENSION OF THE RESIN WAS OBSERVED WHICH MAY HAVE BEEN CREATED DUE TO TENSILE FORCE. 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. WITH USING SIMILAR TYPE OF SHEATH PRODUCT, SHEATH TIP WAS CUT, CLAMPED WITH FORCEPS, AND PULLED. IT WAS CONFIRMED THAT SHEATH WAS FRACTURED IN THE SAME WAY AS THE RETURNED PRODUCT. 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 SECTION SUSPECT MEDICAL DEVICE" IN THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AT THE (B)(6) HOSPITAL IN (B)(6) IT WAS REPORTED THAT WHEN THE MEDIKIT SUPERSHEATH DEVICE FROM LOT NUMBER 16G0737 WAS PULLED OUT, IT WAS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792319 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. 16G0737

    Patients

    Seq Age Sex Outcome Treatment
    1