BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONGOOSE ANGIOGRAPHIC CATHETER

    MDR report key: 7120296 · Received December 15, 2017

    Report

    Report Number
    9612126-2017-00015
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 15, 2017
    Manufacturer
    TOGO MEDIKIT CO.LTD.
    Product Code
    DQO
    PMA / PMN Number
    K113819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS RETURNED. THE RETURNED DEVICE WAS EXAMINED, AND THE REPEATABILITY TEST (TENSILE STRENGTH TESTING ETC.) WAS CONDUCTED USING RESERVED SAMPLES WITH THE SAME LOT NUMBER AS THAT INVOLVED IN THE EVENT. ALSO, THE INVESTIGATION WAS CONDUCTED BY REVIEWING THE RECORDS OF THE MANUFACTURING PROCESSES OF THE ANGIOGRAPHIC CATHETER WITH THE SAME LOT AS THAT INVOLVED IN THE EVENT, AND IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING PROCESSES THAT CAUSED OR CONTRIBUTED TO THE EVENT, AND THERE WERE NO MANUFACTURING RECORDS OF VISUAL INSPECTIONS THAT SHOWED THE CAUSE OF OR CONTRIBUTION TO THE EVENT. JUDGING FROM THIS EXAMINATION, A POSSIBLE CAUSE OF THIS FRACTURE IS THAT CATHETER HAD KINKED INSIDE OF A PATIENT'S BLOOD VESSEL DURING THE PROCEDURE AND CATHETER WAS BENT REPEATEDLY. THIS RESULTED IN A DECREASE IN TENSILE STRENGTH OF THE CATHETER TO A POINT WHERE THE CATHETER COULD NOT WITHSTAND THE PULL FORCE AND FRACTURED. 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 K113819.

    Description of Event or Problem · 1

    ON (B)(6) 2017, AT A HOSPITAL IN (B)(6), IT WAS REPORTED THAT THE TIP OF THE MONGOOSE ANGIOGRAPHIC CATHETER WAS FOUND TO BE FRACTURED DURING A PROCEDURE. THE FRACTURED PORTION OF THE CATHETER WAS REMOVED FROM A PATIENT'S BODY WITH A SNARE CATHETER. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902154 MONGOOSE ANGIOGRAPHIC CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TOGO MEDIKIT CO.LTD. 17I2948

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention