BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11647532 · Received April 12, 2021

    Report

    Report Number
    9681834-2021-00055
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 12, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    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) - K923607, K926214. THE ACTUAL SAMPLE: MAIN BODY AND A FRAGMENT WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF BOTH PORTIONS REVEALED THAT THE FRAGMENT WAS APPROXIMATELY 157 MM AND THE MAIN BODY WAS APPROXIMATELY 2443 MM. TOTAL LENGTH OF BOTH PORTIONS WAS APPROXIMATELY 2600 MM, WHICH WAS EQUIVALENT TO THAT OF A CURRENT PRODUCT; THEREFORE, IT WAS CONCEIVABLE THAT THE ACTUAL SAMPLE HAD NO MISSING PART IN THE SHAFT. MAGNIFYING INSPECTION OF BOTH PORTIONS REVEALED THAT THE OUTER LAYER OF THE FRAGMENT HAD BEEN TAPERED AT THE FRACTURE END ; THE OUTER LAYER OF BOTH PORTIONS SEEMED TO HAVE BEEN PULLED AND TORN AT THE FRACTURE POINT; THE CORE WIRE IN THE MAIN BODY SIDE WAS EXPOSED FROM THE FRACTURE END. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURE END OF BOTH PORTIONS FOUND CREASES AND ELONGATIONS ON THE OUTER LAYER. THE OUTER DIAMETER WAS MEASURED IN THE VICINITY OF THE FRACTURE ENDS AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY IN THE OUTER DIAMETER WAS OBSERVED. THE OUTER LAYER WAS DISSOLVED TO EXPOSE CORE WIRE. ELECTRON MICROSCOPIC INSPECTION OF THE CORE WIRE OF BOTH PORTIONS REVEALED THAT THE END OF THE CORE WIRE WAS STRAIGHT AND NOT TAPERED WHEN SEEN FROM LATERAL SIDE. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF BOTH PORTIONS. MECHANISM OF THE GUIDEWIRE FRACTURE: TERUMO ASHITAKA FACTORY IS AWARE THAT THE GUIDE WIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE FOLLOWING LOADS AND THE FRACTURE SECTION OF THE CORE WIRE PRESENTS SOME REGULARITY DEPENDING ON THE LOAD THE GUIDE WIRE HAS BEEN SUBJECTED TO. ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVED SHAPE. THE FRACTURE END OF CORE WIRE IS STRAIGHT AND NOT TAPERED, AND RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE. REPETITIVE BENDING LOAD. THE FRACTURE END OF THE CORES WIRE IS NOT FLAT AND DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. PULLING LOAD TO THE TEST SAMPLE KEPT IN A LOOP SHAPE. THE FRACTURE END OF THE CORE WIRE HAS BEEN CURVED AND THE FRACTURE SURFACE IS ROUGH. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. PULLING LOAD IN ONE DIRECTION. THE OUTSIDE DIAMETER OF THE CORE WIRE HAS BEEN DIMINISHED TOWARD THE FRACTURE END. THIS STATE IS DIFFERENT FROM THAT OBSERVED ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED 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 PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL SAMPLE WAS EXPOSED TO CONSECUTIVE TORQUE LOAD WHILE ITS DISTAL TIP WAS HELD IN A CURVE SHAPE, WHICH RESULTED IN THE FRACTURE OF THE CORE WIRE DUE TO METAL FATIGUE, AND SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS PULLED IN THE WITHDRAWAL DIRECTION, THE OUTER LAYER WAS TORN, WHICH RESULTED IN THE ACTUAL SAMPLE SEPARATED IN TWO PORTIONS. THE INVESTIGATION RESULT VERIFIED THAT THE TOTAL LENGTH OF THE TWO PORTIONS WAS EQUIVALENT TO THAT OF A CURRENT PRODUCT, IN ADDITION, THE RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF THE CORE WIRE OF BOTH PORTIONS. IT WAS PRESUMED THAT THE ACTUAL SAMPLE HAD NO MISSING PORTION IN THE SHAFT. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED FOR CYSTIC DUCT TREATMENT. THE ACTUAL SAMPLE, AFTER PASSING TORTUOUS AREA, WAS TRAPPED IN A STENOTIC AREA, AND THEN EXPOSED TO CONTINUOUS TORQUE MANIPULATION AND BECAME FRACTURED. THE FRACTURED DISTAL PIECE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545720 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 200922

    Patients

    Seq Age Sex Outcome Treatment
    1