BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11990778 · Received June 14, 2021

    Report

    Report Number
    9681834-2021-00102
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 14, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K863138,K926214. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE CONFIRMED THAT THE DISTAL TIP HAD BEEN FRACTURED. THE TOTAL LENGTH WAS 1488 MM. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THE FRACTURE OF THE OUTER LAYER. THE DISTAL END OF THE CORE WIRE SEEMED TO LOCATE AT APPROX. 6 MM FROM THE DISTAL END, AND THE OUTER LAYER AROUND THIS AREA WAS DEFORMED IN TAPERED SHAPE. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE DISTAL END OF THE OUTER LAYER SEEMED TO HAVE BEEN PULLED AND TORN OFF. MULTIPLE CREASES DUE TO ELONGATION OF OUTER LAYER WERE OBSERVED FROM THE DISTAL END TO APPROX. 6 MM FROM THE DISTAL END. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED NEAR THE FRACTURE AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. THE OUTER LAYER OF THE ACTUAL SAMPLE WAS REMOVED, AND THE APPEARANCE OF THE CORE WIRE WAS CHECKED UNDER AN ELECTRON MICROSCOPE. THE CORE WIRE TIP HAD NOT BEEN DEFORMED IN TAPERED SHAPE. DIMPLE PATTERNS WERE OBSERVED ON THE FRACTURE SURFACE OF THE CORE WIRE. THE LENGTH OF THE CORE WIRE OF THE ACTUAL SAMPLE WAS CONFIRMED TO BE 1482 MM. AS THE NORMAL LENGTH OF THIS PRODUCT TYPE IS 1500 MM, IT IS LIKELY THAT THE DISTAL 18 MM IN LENGTH WAS MISSING. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THERE WAS NO ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR REPORT FOR THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. THE MECHANISM OF THE GUIDEWIRE FRACTURE WAS TESTED. BASED ON THE PREVIOUS REPRODUCTIVE TEST RESULTS, TERUMO ASHITAKA FACTORY IS AWARE THAT THE GUIDE WIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED BELOW, AND THE FRACTURE SURFACE OF THE CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE LOAD THE GUIDE WIRE HAS BEEN SUBJECTED TO. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE WAS TESTED. THE FRACTURE END OF THE CORE WIRE IS NOT DEFORMED IN TAPERED SHAPE, AND DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE IS LIKE THIS STATE. A ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVED SHAPE WAS TESTED. THE FRACTURE END OF THE CORE WIRE IS FLAT AND NOT TAPERED. RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. PULLING LOAD TO THE TEST SAMPLE KEPT IN A LOOP SHAPE SHOWED THE FRACTURE END OF THE CORE WIRE BECOMES CURVED AND THE FRACTURE SURFACE IS ROUGH. IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. ONE-WAY PULLING LOAD WAS SHOWED THAT THE FRACTURE END OF THE CORE WIRE HAD BEEN TAPERED. IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. 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. BASED ON THE INVESTIGATION RESULTS, IT IS LIKELY THAT THE CORE WIRE OF THE ACTUAL SAMPLE WAS FRACTURED DUE TO METAL FATIGUE CAUSED BY REPEATED BENDING LOADS APPLIED WHEN THE ACTUAL SAMPLE PASSED THROUGH THE STENOTIC LESION. AFTER THAT, IT WAS THOUGHT THAT THE OUTER LAYER WAS STRETCHED, SHREDDED, AND SEPARATED BY THE PULLING LOAD DURING GUIDEWIRE REMOVAL MANIPULATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE RADIFOCUS GUIDEWIRE M WAS USED DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A 0.018-INCH-COMPATIBLE OTW BALLOON WAS CONCURRENTLY USED IN PLACE OF A MICROCATHETER AND THE GUIDEWIRE WAS ADVANCED TO THE OCCLUSION BEYOND TORTUOSITY. AS THE TIP BECAME STUCK, THEY PULLED OUT THE GUIDEWIRE AND FELT RESISTANCE. AS A RESULT, THE TIP FRACTURED, THEY ATTEMPTED TO RECOVER IT HOWEVER IT FAILED. THE FRAGMENT WAS LEFT IN THE BODY. THE FRAGMENT LEFT IN THE BODY IS IRRETRIEVABLE. THE FINAL PATIENT IMPACT WAS NO-SERIOUS. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886945 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 201216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0.018YOROI AND OTW BALLOON