BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 14072857 · Received April 11, 2022

    Report

    Report Number
    9681834-2022-00055
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 11, 2022
    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 - 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. 510(K) NO: K863138,K926214. ONE ACTUAL SAMPLE (A FRAGMENT AND A MAIN BODY) AND FOUR UNOPENED SAMPLES FROM THE INVOLVED PRODUCT CODE/LOT WERE RETURNED. INSPECTION OF THE ACTUAL SAMPLE AND THE FOUR UNOPENED SAMPLES WERE CONDUCTED. VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE MAIN BODY MEASURED APPROX. 1415 MM AND THE FRAGMENT MEASURED APPROX. 85 MM. AS THE NORMAL LENGTH OF THIS PRODUCT IS 1500 MM, IT WAS CONSIDERED THAT NO PORTION WAS MISSING FROM THE ACTUAL SAMPLE. A DEFORMITY WAS OBSERVED ON THE MAIN BODY, AT APPROX. 300 MM FROM THE FRACTURE. THE FOUR UNOPENED SAMPLES WERE TAKEN OUT FROM THE PACKAGE AND SUBJECTED TO VISUAL INSPECTION. NO FRACTURE, DEFORMITY OR OTHER ANOMALY WAS OBSERVED IN THE APPEARANCE. MAGNIFYING INSPECTION OF ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULTS. ON THE FRACTURED END OF THE FRAGMENT, THE CORE WIRE WAS EXPOSED. ON THE FRACTURED END OF THE MAIN BODY, THE OUTER LAYER HAD BEEN STRETCHED. THE SHAPE OF THE FRACTURED OUTER LAYER MATCHED TO EACH OTHER. ON THE DEFORMED AREA THERE WAS NO PEELING OF OUTER LAYER WAS OBSERVED. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE OBTAINED THE FOLLOWING RESULTS. ON THE FRACTURED AREA THE OUTER LAYER SEEMED TO HAVE BEEN PULLED AND TORN. MULTIPLE CREASES WERE OBSERVED ON THE OUTER LAYER SURFACE. ON THE DEFORMED AREA THERE WAS NO SCRATCHED OR OTHER ANOMALY WAS OBSERVED ON THE OUTER LAYER. (NOTE: THE HYDROPHILIC COATING GETS SWOLLEN WHEN IT CONTAINS MOISTURE. IN THE DRY STATE, IT GETS CRACKED IN THE PECULIAR WAY. THE CRACK PATTERN HAS SOME INTER-INDIVIDUAL DEFERENCE BY PRODUCT.) THE OUTER DIAMETER OF THE ACTUAL SAMPLE AND THE FOUR SAMPLES FROM THE INVOLVED PRODUCT CODE/LOT WERE MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL STANDARDS. THE OUTER LAYER OF THE ACTUAL SAMPLE WAS REMOVED AND THE STATE OF THE CORE WIRE WAS INSPECTED UNDER AN ELECTROM MICROSCOPE. FOR BOTH THE FRAGMENT AND THE MAIN BODY, THE FRACTURE ENDS WERE FLAT AND HAD NOT BEEN DEFORMED IN TAPER. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF BOTH ENDS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THERE WAS NO PROBLEM IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORTS WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. SIMULATION TEST/ MECHANISM OF FRACTURE OF GUIDEWIRES. IT IS KNOWN FROM OUR PAST EXPERIMENTS THAT THE GUIDEWIRE 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 END PRESENTS SOME REGULARITY DEPENDING ON THE FRACTURE MECHANISM. CONTINUOUS ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVE SHAPE; (I) THE FRACTURED ENDS ARE FLAT, NOT CURVED OR DEFORMED IN TAPER. RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE WAS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE. REPETITIVE BENDING LOAD AT A 90-DEGREE ANGLE; (I) THE FRACTURED ENDS ARE NOT CURVED OR DEFORMED IN TAPER, BUT DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. FROM THIS, IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. ONE-WAY PULLING LOAD; (I) THE FRACTURED ENDS HAVE BEEN DEFORMED IN TAPER. FROM THIS, IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. PULLING LOAD TO A LOOP-SHAPED TEST SAMPLE; (I) THE FRACTURED ENDS HAVE BEEN CURVED AND DEFORMED IN TAPER, AND FRACTURE SURFACE IS ROUGH. FROM THIS, IT IS PRESUMED THAT THE ACTUAL SAMPLE WAS NOT FRACTURED BY THIS MECHANISM. BASED ON THE RESULTS OF THE INVESTIGATION AND THE SIMULATION TESTS, IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS SUBJECTED TO A CONTINUOUS TORQUE LOAD WHILE IT WAS KEPT CURVED, WHICH RESULTED IN THE FRACTURE OF THE CORE WIRE AT APPROX. 85 MM FROM THE DISTAL END DUE TO METAL FATIGUE. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS SUBJECTED TO A PULLING LOAD DURING REMOVAL OPERATION, THE OUTER LAYER BECAME TORN, WHICH RESULTED IN THE COMPLETE SEPARATION OF THE SHAFT INTO TWO PORTIONS AND THE FRAGMENT REMAINING IN THE PATIENT. SINCE THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS CONFIRMED TO BE EQUIVALENT TO THAT OF THE NORMAL PRODUCT, IT WAS CONSIDERED THAT NO PORTION WAS MISSING FROM THE ACTUAL SAMPLE. THE CAUSE OF THE DEFORMITY ON THE MAIN BODY COULD NOT BE CLARIFIED FROM THE STATE OF THE ACTUAL SAMPLE SINCE THE DETAILS ABOUT THE OCCURRENCE SITUATION WAS UNKNOWN. THE FOUR UNOPENED SAMPLES WERE CONSIDERED TO BE NORMAL PRODUCTS SINE NO ANOMALY WAS NOTED IN THEIR APPEARANCE CONDITION OR DIMENSIONS. RELEVANT IFU REFERENCE: "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." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE INVOLVED WAS USED DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PRODUCT RUPTURED INSIDE THE PATIENT'S BODY. THE RUPTURED FRAGMENT WAS SURGICALLY REMOVED ON SITE. SURGICAL INTERVENTION WAS PERFORMED TO EXTRACT THE BROKEN PIECE. THE PATIENT'S FINAL IMPACT WAS HARMED BUT NON SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901508 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 211111YA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Other RR-A60G05A, BSJ MUSTANG 39171-05024