BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE ADVANTAGE

    MDR report key: 18004169 · Received October 25, 2023

    Report

    Report Number
    9681834-2023-00206
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 25, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: PHONE NUMBER: UNKNOWN. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: OTHERS. G4: PMA/510(K): K122590, K163004. VISUAL INSPECTION OF THE ACTUAL SAMPLE (UNAIDED EYE, MICROSCOPE, AND SEM) FOUND NO ANOMALY SUCH AS A FRACTURE WAS FOUND IN THE APPEARANCE ALONG THE ENTIRE LENGTH. THE URETHANE HAD BEEN DAMAGED AT THE DISTAL END. THERE WAS NO BREAKAGE OR OTHER ANOMALY IN OTHER PARTS. A TRACE OF SIZING CUT PERFORMED IN OUR PRODUCTION PROCESS WAS OBSERVED ON THE DISTAL END. FROM THIS, IT WAS PRESUMED THAT THERE WAS NO MISSING SECTION IN THE CORE WIRE. X-RAY FLUOROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND NO FRACTURE IN THE COIL. COMPARISON WITH A CURRENT PRODUCT SAMPLE (X-RAY FLUOROSCOPE) FOUND THAT THE COIL PITCH OF THE ACTUAL SAMPLE WAS FOUND SPARSER THAN THAT OF THE CURRENT PRODUCT SAMPLE. THE DISTAL END OF THE CORE WIRE OF THE CURRENT PRODUCT SAMPLE WAS LOCATED AT THE DISTAL END OF THE OUTER LAYER. FROM THIS, IT WAS PRESUMED THAT THE URETHANE OF THE ACTUAL SAMPLE HAD BEEN ELONGATED. THE OUTER DIAMETER OF THE HYDROPHILIC COATED PART AND THE OUTER DIAMETER OF THE PTFE COATED PART WERE CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT NUMBER FOUND NO ANOMALY IN THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FROM OTHER FACILITIES. FROM THE INVESTIGATION RESULTS, AS ONE OF POSSIBILITIES, IT WAS PRESUMED THAT TENSILE FORCE WAS APPLIED TO THE DISTAL PART OF THE ACTUAL SAMPLE, CAUSING DAMAGE TO THE URETHANE; HOWEVER, THE TIMING OF OCCURRENCE COULD NOT BE CLARIFIED BECAUSE THE DETAILS AT THE TIME OF USE WERE UNKNOWN. RELEVANT IFU REFERENCE: "DO NOT USE IF THE UNIT PACKAGE OR THE GUIDE WIRE IS BROKEN OR SOILED." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GUIDEWIRE WAS DAMAGED. THE END OF THE GUIDE WAS DEFECTIVE WHEN OPENED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926199 RADIFOCUS GUIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 230306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown