BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 17283695 · Received July 7, 2023

    Report

    Report Number
    9681834-2023-00133
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    May 18, 2023
    Report Date
    July 7, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: OTHERS. G4: 510(K) NO:K063372, K122590, K163004. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE WAS CONDUCTED. THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER. THE GUIDEWIRE WAS PROTRUDING APPROXIMATELY 1450 MM FROM THE CATHETER. AS THE SPECIFIED LENGTH OF THIS PRODUCT CODE IS 3000MM, THE PART OF THE GUIDEWIRE STICKING INSIDE THE CATHETER WAS PRESUMED TO BE APPROXIMATELY 1550MM. MAGNIFYING INSPECTION OF THE GUIDEWIRE FOUND PEELING OF PTFE COATING AT APPROXIMATELY 1950MM, 2310MM, 2320MM, 2330MM FROM THE DISTAL END OF GUIDEWIRE AND AT THE PROXIMAL END OF SHAFT. THE GUIDEWIRE WAS REMOVED FROM DISASSEMBLED CATHETER. MAGNIFYING INSPECTION FOUND PEELING OF PTFE COATING AT APPROXIMATELY 1500MM FROM THE DISTAL END OF GUIDEWIRE. FUNCTION CONFIRMATION OF THE OUTER DIAMETER OF THE GUIDEWIRE WAS CONFIRMED TO BE WITHIN THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS OBSERVED. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT #. NO ANOMALY WAS FOUND. THE PAST COMPLAINT FILE OF THE INVOLVED PRODUCT CODE/LOT #. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. SIMULATION TEST WAS CONDUCTED. THE FOLLOWING SIMULATION TEST HAVE BEEN CARRIED OUT IN THE PAST. A GLIDEWIRE ADVANTAGE TEST SAMPLE WAS WITHDRAWN FROM A METAL DEVICE ASSUMING A CASE WHERE IT WAS PULLED WHILE BENT AND EXPOSED STRONGLY TO A METAL DEVICE. AS A RESULT, THE PTFE COATING PEELED OFF. FROM THE INVESTIGATION RESULTS INCLUDING THE SIMULATION TEST RESULT, IT WAS THOUGHT THAT THE PTFE COATING PEELED OFF DUE TO THE REMOVAL OPERATION OF THE GUIDEWIRE BEING PERFORMED WHILE SOME KIND OF HARD OBJECT (E.G., METAL DEVICE) BEING IN CONTACT; HOWEVER, THE DETAILS OF THE PROCEDURE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE TIMING OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT USE THE GLIDEWIRE ADVANTAGE WITH DEVICE WHICH CONTAIN METAL PARTS SUCH AS ATHERECTOMY CATHETERS, LASER CATHETERS, OR METALINTRODUCTION DEVICE AS THEY MAY CAUSE THE GLIDEWIRE ADVANTAGE PLASTIC COATING TO SHEAR AND/OR SEVER THE WIRE." 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 INVOLVED GUIDE WIRE WAS BLOCKED IN THE CATHETER. A NAVICROSS WAS USED TOGETHER WITH THE GWA RA*FA18301CM DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AS THE USER WANTED TO PULL BACK THE GWA IT GOT STUCK. THEN BOTH DEVICES HAD TO BE PULLED OUT TOGETHER. THE WIRE WAS KEPT WET AND THE NAVICROSS WAS FLUSHED. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT FINAL IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150687 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 221128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NAVICROSS(PN*NA18153HM)