BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 8379761 · Received February 28, 2019

    Report

    Report Number
    9681834-2019-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 28, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 THE ACTUAL GUIDEWIRE DEVICE AND THE ANGIOGRAPHIC CATHETER USED IN COMBINATION WITH THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE GUIDEWIRE REVEALED THAT IT HAD BEEN KINKED AT APPROX. 30MM AND 40MM FROM THE DISTAL END OF THE DEVICE. ON THE KINK AT APPROXIMATELY 40MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER WAS NOTED TO HAVE BEEN BROKEN. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE KINKED SECTION AT APPROXIMATELY 30MM FROM THE DISTAL END OF THE DEVICE FOUND THAT SOME ABRASIONS HAD BEEN GENERATED ON THE SURFACE OF THE URETHANE OUTER LAYER. MAGNIFYING AND ELECTRON MICROSCOPIC INSPECTIONS OF THE URETHANE OUTER LAYER-BROKEN SECTION AT APPROX. 40MM FROM THE DISTAL END OF THE DEVICE FOUND THAT THE BROKEN SECTION HAD THE CONFIGURATION IMPLYING THAT THE URETHANE OUTER LAYER HAD BEEN RIPPED WITH THE GENERATION OF SOME ABRASIONS, CREASES AND TEARS AROUND THE BROKEN SECTION. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SECTION AND FOUND TO MEET THE SPECIFICATIONS. VISUAL INSPECTION OF THE ANGIOGRAPHIC CATHETER REVEALED THAT THE SHAFT HAD BEEN TORN ON APPROXIMATELY 35 - 405MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION DID NOT REVEAL ANY OTHER ANOMALY THAN THE TEAR. THE OUTSIDE AND INSIDE DIAMETERS WERE MEASURED ON THE UNDAMAGED SECTION AND CONFIRMED TO MEET THE SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED ON AN ANGIOGRAPHIC CATHETER SAMPLE AND A GUIDEWIRE SAMPLE. A KINK WAS GIVEN TO THE CATHETER ON THE DISTAL SIDE-HOLED SECTION. THE GUIDEWIRE WAS ADVANCED INTO THE CATHETER AND LET TO GO OUT THROUGH ONE OF THE SIDE HOLES ON THE KINKED SECTION WITH APPLICATION OF PUSHING FORCE. A KINK WAS GIVEN TO THE GUIDEWIRE ON THE SECTION PROTRUDING FROM THE SIDE HOLE OF THE CATHETER. IN THIS STATE, THE GUIDEWIRE WAS SUBJECTED TO EXCESSIVE PULLING FORCE. THIS RESULTED IN THE GENERATION OF A TEAR ON THE CATHETER SHAFT. A REVIEW OF THE REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT /LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS ADVANCED INTO THE INVOLVED CATHETER WHICH HAD ALREADY HAD A KINK ON THE DISTAL SIDE-HOLED SECTION. THE ACTUAL SAMPLE GOT INTO ONE OF THE SIDE HOLES ON THE KINKED SECTION AND PROTRUDED FROM THE HOLE. DURING FURTHER MANIPULATIONS TO ADVANCE THE ACTUAL SAMPLE, PUSHING FORCE KINKED THE ACTUAL SAMPLE ON THE SECTION PROTRUDING FROM THE INVOLVED CATHETER. SUBSEQUENTLY, DURING MANIPULATIONS TO WITHDRAW THE ACTUAL SAMPLE, ITS KINKED SECTION WAS CAUGHT IN THE SIDE HOLE OF THE INVOLVED CATHETER AND TORE THE CATHETER SHAFT. AT THE SAME TIME, THE URETHANE OUTER LAYER THE ACTUAL SAMPLE GOT RIPPED ON THE KINKED SECTION. HOWEVER, IT IS DIFFICULT TO DEFINITIVELY DETERMINE THE CAUSE OF THE ISSUE BASED ON THE AVAILABLE INFORMATION. IFU STATES: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE M AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GUIDE WIRE M OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHILE WITHDRAWING THE ACTUAL GUIDEWIRE SAMPLE FROM THE ACTUAL CATHETER SAMPLE, THE OPERATOR FELT HIGH RESISTANCE. SUBSEQUENTLY, HE FOUND THAT THE ACTUAL CATHETER SAMPLE HAD BEEN DEFORMED AND THE ACTUAL GUIDEWIRE SAMPLE HAD BEEN ALMOST RIPPED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A 4FR TERUMO SHEATH WAS USED WITH THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171476 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180906T

    Patients

    Seq Age Sex Outcome Treatment
    1