BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 15333354 · Received September 1, 2022

    Report

    Report Number
    9681834-2022-00165
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 3, 2022
    Report Date
    September 1, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 29-FEB-2022 (DATE WAS FILLED IN HOWEVER AFTER PACKAGING IT WAS BLANK). UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K863138,K926214. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT OBTAINED FOLLOWING: (I) THE DISTAL END OF ACTUAL SAMPLE HAD BEEN FRACTURED; (II) THE TOTAL LENGTH OF ACTUAL SAMPLE WAS APPROXIMATELY 1770MM. SINCE THE NORMAL PRODUCT IS APPROXIMATELY 1800MM, IT WAS LIKELY THAT THE ACTUAL SAMPLE WAS MISSING APPROXIMATELY 30MM. MAGNIFYING INSPECTION OF THE FRACTURED SECTION OBTAINED THAT THE WIRE HAD BEEN EXPOSED AND A DENT SHAPE WAS FOUND. MAGNIFYING INSPECTION OF THE FRACTURED SURFACE FOUND A SMOOTH SHAPE. MAGNIFYING INSPECTION OF THE OTHER SECTIONS OBTAINED FOLLOWING RESULTS: (I) IT HAD BEEN ABRADED AT APPROXIMATELY 40MM FROM THE FRACTURED SECTION; (II) THE WIRE HAD BEEN EXPOSED AND THE WRINKLE WAS FOUND AT APPROXIMATELY 1000MM FROM THE FRACTURED SECTION; (III) NO ANOMALY SUCH AS A SCRATCH WAS FOUND AT APPROXIMATELY 500MM AND 1500MM FROM THE FRACTURED SECTION, AND AT THE REAR END. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED SECTION FOUND THAT THE OUTER LAYER HAD BEEN WRINKLED. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED SURFACE FOUND STREAK PATTERNS. THEN, ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED SURFACE OF WIRE OBTAINED STREAK PATTERNS AND DIMPLE PATTERNS WERE FOUND. X-RAY FLUOROSCOPIC INSPECTION OF THE FRACTURED SECTION FOUND THAT THE WIRE HAD BEEN TAPERED. FROM INVESTIGATION OF THE ACTUAL SAMPLE, IT WAS INFERRED THAT CLIPPING FORCE WAS APPLIED WHILE SOME OBJECT WAS IN CONTACT WITH THE ACTUAL SAMPLE. THE OUTER DIAMETER OTHER THAN THE FRACTURED SECTION WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION OBTAINED FOLLOWING RESULTS: (I) NO PRODUCT WITH A FRACTURED DISTAL END OF GUIDEWIRE WHICH WAS SIMILAR TO THE ACTUAL SAMPLE FOUND; (II) THE PRODUCTION QUANTITY AND PACKAGING QUANTITY WERE CONFIRMED. NO DIFFERENCE WAS FOUND; (III) NO PRODUCT RETURNED TO THE PROCESS DUE TO THE CRUSHED BOX OR DEVIATION WAS FOUND. ASHITAKA FACTORY MANUFACTURING PROCESS ASSURES THE QUALITY OF THIS PRODUCT BY PERFORMING FOLLOWING WORK AND INSPECTIONS. WHEN INSERTING THE GUIDEWIRE INTO THE HOLDER TUBE, INSERT IT WHILE CONFIRMING THE APPEARANCE OF GUIDEWIRE ON 100% BASIS. BEFORE THE CARTOONING PROCESSES, 100% VISUAL INSPECTION IS PERFORMED TO CONFIRM THAT THERE IS NO ANOMALY IN THE GUIDEWIRE. WE HAVE RECONFIRMED THAT THE ABOVE ASSURANCE SYSTEM WAS BEING PERFORMED NORMALLY. IN ORDER TO INVESTIGATE THE POSSIBILITY THAT THE PRODUCT WITH A FRACTURED DISTAL END OF GUIDEWIRE WAS CONTAMINATED, THE MANUFACTURING PROCESS WAS CONFIRMED. FOLLOWING RESULTS WERE OBTAINED: (I) BEFORE AND AFTER THE PRODUCTION OF THE PRODUCTS WITH THE INVOLVED PRODUCT CODE, NO NONCONFORMING PRODUCT WITH A FRACTURED DISTAL END OF GUIDEWIRE OR WITH THE POSSIBILITY OF FRACTURE WAS FOUND; (II) IN ORDER TO PREVENT CONTAMINATION OF PRODUCTS PRODUCED IMMEDIATELY BEFORE, LINE CLEARANCE WAS PERFORMED BEFORE THE START OF PRODUCTION. FROM INVESTIGATION OF THE ACTUAL SAMPLE MANUFACTURING RECORD AND PROCESS , SINCE NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS AND THE SHIPPING INSPECTION RECORD, AND THE ASSURANCE SYSTEM IN THE MANUFACTURING PROCESS WAS BEING PERFORMED NORMALLY, IT WAS LIKELY THAT THERE WAS NO PROBLEM IN THE PROCESS. FROM INVESTIGATION OF THE ACTUAL SAMPLE POSSIBILITY THAT THE PRODUCT WITH A FRACTURED DISTAL END IT WAS LIKELY THAT IN THE PROCESS, THERE IS NO POSSIBILITY OF CONTAMINATION WITH THE PRODUCT WITH A FRACTURED DISTAL END OF GUIDEWIRE OR PRODUCT WITH THE POSSIBILITY OF FRACTURE. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. BASED ON INVESTIGATION OF THE ACTUAL SAMPLE MAGNIFYING INSPECTION OF THE FRACTURED SECTION, SINCE THE ASSURANCE SYSTEM IN THE MANUFACTURING PROCESS WAS BEING PERFORMED NORMALLY, AND NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS AND THE SHIPPING INSPECTION RECORD, IT WAS LIKELY THAT THERE WAS NO PROBLEM IN THE PROCESS. IN ADDITION, BASED ON INVESTIGATION OF THE ACTUAL SAMPLE MAGNIFYING INSPECTION OF THE OTHER SECTIONS, IT WAS LIKELY THAT BEFORE AND AFTER THE PRODUCTION OF THE PRODUCTS WITH THE INVOLVED PRODUCT CODE, THERE IS NO POSSIBILITY OF CONTAMINATION WITH THE PRODUCT WITH A FRACTURED DISTAL END OF GUIDEWIRE OR PRODUCT WITH THE POSSIBILITY OF FRACTURE. DUE TO THESE FACTORS, IT WAS NOT POSSIBLE TO IDENTIFY THE CAUSE OF WHEN THE INVOLVED PRODUCT WAS INSERTED INTO THE SHEATH, IT WAS FOUND THAT THERE WAS NO ANGLE AT THE DISTAL END DESCRIBED IN THE REPORTED ISSUE. FROM THE STATE OF ACTUAL SAMPLE, IT WAS INFERRED THAT CLIPPING FORCE WAS APPLIED WHILE SOME OBJECT WAS IN CONTACT, CAUSING THE OUTER LAYER AND THE WIRE TO FRACTURE AND MISSING. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)WAS ATTEMPTED FOR STENOSIS AT THE ANASTOMOSIS SITE OF THE GRAFT IN THE SUBCLAVIAN ARTERY. WHEN THE INVOLVED RADIFOCUS GUIDEWIRE M PRODUCT WAS INSERTED INTO THE SHEATH, IT WAS FOUND THAT THERE WAS NO ANGLE AT THE DISTAL END. THE USE OF THIS PRODUCT WAS DISCONTINUED, AND THE COOK ROSEN WIRE WAS USED. AN EPIC STENT WAS PLACED IN THE TREATED AREA AND THE CASE WAS SUCCESSFULLY COMPLETED. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED TO PREVENT INJURY. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THE PATIENT'S FINAL IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635308 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 220308YA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 6FR SHORT SHEATH (MEDIKIT), 5FR COBRA (MEDIKIT)| EPIC STENT 12-40, EPIC STENT 10-60| ROSEN WIRE GUIDE (COOK MEDICAL),