BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 12827128 · Received November 17, 2021

    Report

    Report Number
    9681834-2021-00208
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 17, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED IN TWO PORTIONS. THE FRAGMENT AND THE MAIN BODY MEASURED APPROXIMATELY 74 MM AND 2526 MM IN LENGTH RESPECTIVELY. AS THE NORMAL LENGTH OF THIS PRODUCT TYPE IS 2600 MM, IT WAS CONCEIVED THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE CORE WIRE WAS EXPOSED ON THE FRACTURED AREA OF BOTH THE FRAGMENT AND THE MAIN BODY. A PART OF THE OUTER LAYER OF THE FRACTURED AREA ON THE FRAGMENT SIDE LOOKED LIKE IT WAS COMPRESSED. NO DAMAGE OR OTHER ABNORMALITY WAS OBSERVED IN THE AREAS OTHER THAN THE FRACTURE SITE. ELECTRON MICROSCOPIC INSPECTION OF THE FRACTURED AREA FOUND CREASES ON THE OUTER LAYER SURFACE. THE FRACTURE END OF THE OUTER LAYER SEEMED TO HAVE BEEN TORN OFF. CRACKLE PATTERN PECULIAR TO THE HYDROPHILIC COAT WERE OBSERVED IN PLACES OTHER THAN THE FRACTURED AREA. THEREFORE, IT WAS CONSIDERED THAT THE HYDROPHILIC COAT HAD BEEN PROPERLY APPLIED TO THE ACTUAL SAMPLE. (NOTE: THE HYDROPHILIC COATING GETS SWOLLEN WHEN IT IS MOISTENED. THEREFORE, IN THE DRY STATE, IT GETS CRACKLED.) THE SLIDING RESISTANCE WHEN THE ACTUAL SAMPLE WAS PASSING A VALVE WAS MEASURED AND FOUND TO BE EQUIVALENT TO THAT OF A CURRENT NORMAL PRODUCT. NO ANOMALY WAS OBSERVED. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED ON THE UNDAMAGED AREA AND CONFIRMED TO MEET THE FACTORY'S CONTROL STANDARDS. NO ANOMALY WAS OBSERVED. THE OUTER LAYER WAS REMOVED FROM THE ACTUAL SAMPLE. ELECTRON MICROSCOPIC INSPECTION OF THE CORE WIRE FOUND THAT BOTH FRACTURE ENDS WERE FLAT AND NOT TAPERED IN DIAMETER. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF BOTH PORTIONS. MECHANISM OF FRACTURE OF CORE WIRE: IT IS KNOWN FROM OUR PAST EXPERIMENTS THAT THE GUIDE WIRE MAY GET FRACTURED WHEN IT HAS BEEN SUBJECTED TO ONE OF THE LOADS DESCRIBED BELOW. IN ADDITION, AS FOR THE CORE WIRE, THE STATE OF THE FRACTURED ENDS PRESENTS SOME REGULARITY DEPENDING ON THE MECHANISM OF THE BREAKAGE. CONTINUOUS ONE-WAY TORQUE LOAD TO A BENT GUIDEWIRE: THE FRACTURED ENDS OF CORE WIRE ARE FLAT AND NOT TAPERED. RADIAL PATTERN IS OBSERVED ON THE BROKEN SURFACE. THIS STATE IS SIMILAR TO THAT OBSERVED IN THE ACTUAL SAMPLE. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE: THE FRACTURED ENDS OF CORE WIRE ARE NOT TAPERED. DIMPLE PATTERN WAS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS DIFFERENT FROM THAT OBSERVED IN THE ACTUAL SAMPLE. ONE-WAY PULLING LOAD: THE FRACTURED ENDS OF THE CORE WIRE ARE TAPERED IN DIAMETER. THIS STATE IS DIFFERENT FROM THAT OBSERVED IN THE ACTUAL SAMPLE. PULLING LOAD TO A TEST SAMPLE KEPT IN A LOOP SHAPE: THE FRACTURED ENDS OF THE CORE WIRE HAVE BEEN CURVED AND TAPERED. THE FRACTURE SURFACE IS ROUGH. THIS STATE IS DIFFERENT FROM THAT OBSERVED IN THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND 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 PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ACCORDING TO THE RESULTS OF THE INVESTIGATION, NO ANOMALY WAS FOUND IN THE DIMENSIONS AND SLIDING PROPERTIES OF THE ACTUAL SAMPLE. BASED ON THE RESULTS OF THE SIMULATION TEST, IT WAS PRESUMED THAT THE ACTUAL SAMPLE IN A BENT STATE MIGHT HAVE BEEN SUBJECTED TO CONTINUOUS TORQUE LOAD, WHICH RESULTED THAT THE CORE WIRE ONLY WAS FRACTURED AT APPROXIMATELY 74 MM FROM THE DISTAL END DUE TO METAL FATIGUE. AS THE PHYSICIAN CONTINUED THE PROCEDURE IN THAT STATE, IT WAS POSSIBLE THAT THE TORQUE OR PUSHING OPERATION WAS NOT TRANSMITTED TO THE TIP OF THE ACTUAL SAMPLE AND HE FELT AS IF THERE WAS RESISTANCE. IT WAS LIKELY THAT THE OUTER LAYER WAS TORN AND SEPARATED WHEN THE ACTUAL SAMPLE WAS PULLED OUT, WHICH RESULTED THAT THE DISTAL PART OF THE ACTUAL SAMPLE WAS LEFT IN THE PATIENT'S BODY. THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS VERIFIED TO BE EQUIVALENT TO THAT OF THE CURRENT NORMAL SAMPLE, IT WAS PRESUMED THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED DURING THE ERCP CASE. THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH A CATHETER FROM ANOTHER MANUFACTURER TO SEARCH FOR A SIDE BRANCH, THE OPERATOR FELT UNUSUAL RESISTANCE, BUT CONTINUED THE PROCEDURE. WHEN THE ACTUAL SAMPLE WAS REMOVED UNDER RESISTANCE, THE DISTAL TIP WAS FOUND BROKEN OFF. THE BROKEN PIECE WAS RETRIEVED WITH FORCEPS. THE OPERATOR FELT THAT THE COATING MIGHT HAVE BEEN DIFFERENT THAN USUAL. THE GUIDEWIRE FRACTURED AND MEDICAL INTERVENTION WAS PERFORMED TO RETRIEVE IT. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728667 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 210217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention MTW CATHETER