BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 17831626 · Received September 28, 2023

    Report

    Report Number
    9681834-2023-00192
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 27, 2023
    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

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO CORRECT SECTION D3.

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. G4: PMA/510(K): K863138, K926214. 1. INSPECTION OF THE ACTUAL SAMPLE: 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE, LENGTH OF THE FRAGMENT: APPROXIMATELY 34 MM, LENGTH OF THE MAIN BODY: APPROXIMATELY 3962 MM, TOTAL LENGTH: APPROXIMATELY 3996 MM (FACTORYRETAINED NORMAL PRODUCT: APPROXIMATELY 3999 MM). 1.2. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE THE CORE WIRE WAS EXPOSED AT THE FRACTURE OF THE FRAGMENT. ROUGHNESS WAS OBSERVED NEAR THE FRACTURE OF THE FRAGMENT. THE EDGE OF THE FRACTURED OUTER LAYER OF MAIN BODY WAS STRETCHED. NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. 1.3. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE: WRINKLES WERE OBSERVED ON THE OUTER LAYER NEAR THE FRACTURE OF BOTH PORTIONS. THE FRACTURED EDGE OF THE OUTER LAYER OF BOTH PORTIONS SHOWED A SHREDDEDLIKE SHAPE. THERE WAS A SCRATCH ON THE FRACTURE OF THE FRAGMENT. THE TOP SURFACE OF THE FRACTURE OF THE FRAGMENT WAS IN A SHAPE AS IF THE OUTER LAYER WAS ROLLED INWARD. FROM THIS, IT WAS CONSIDERED THAT A HARD OBJECT HAD COME INTO CONTACT WITH THE VICINITY OF THE FRACTURE POINT OF THE FRAGMENT. 1.4. DIMENSIONAL INSPECTION: OUTER DIAMETER (UNDAMAGED AREA NEAR THE FRACTURE): IT WAS WITHIN THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. 1.5. THE OUTER LAYER WAS REMOVED, AND THE CORE WIRES AT THE FRACTURE WAS SUBJECTED TO AN ELECTRON MICROSCOPIC INSPECTION. THE CORE WIRE OF THE FRAGMENT WAS TAPERED. THE CORE WIRE OF THE MAIN BODY WAS NOT DEFORMED IN TAPER SHAPE. THE FRACTURE SURFACE OF THE CORE WIRE OF THE FRAGMENT WAS A ROUGH. THE FRACTURE SURFACE OF THE CORE WIRE OF THE BODY HAD A RADIAL PATTERN. FROM THIS, IT WAS INFERRED THAT FRACTURE HAD OCCURRED AT MULTIPLE POINTS OF THE ACTUAL SAMPLE AT DIFFERENT TIMING BECAUSE OF THE DIFFERENT FRACTURE SURFACE CONDITIONS. THEREFORE, THE ACTUAL SAMPLE WAS CONSIDERED TO BE PARTIALLY DEFICIENT. 2. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE/LOT NUMBER: NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FROM OTHER FACILITIES. 3. PAST SIMULATION TEST: THE FOLLOWING SIMULATION TESTS WERE CONDUCTED IN THE PAST BASED ON OUR EXPERIENCE AND KNOWLEDGE ON THE GUIDEWIRE FRACTURE. WE HAVE BEEN AWARE THAT THERE IS REGULARITY IN THE CONDITION OF THE FRACTURED CORE WIRE DEPENDING ON THE MECHANISM LEADING TO THE FRACTURE. WHEN ONEWAY CONTINUOUS TORQUE FORCE IS APPLIED TO A CURVED GUIDEWIRE, THE END OF FRACTURED CORE WIRE BECOMES FLAT, NO TAPERING IS OBSERVED ON THE SIDE, AND RADIAL PATTERN IS GENERATED ON THE FRACTURE SURFACE. THIS RESULT WAS CONSIDERED SIMILAR TO THE CONDITION OF THE FRACTURE OF THE MAIN BODY. WHEN TENSILE FORCE IS APPLIED TO A GUIDEWIRE WHILE ITS DISTAL END IS IN TRAPPED STATE, THE SIDE OF FRACTURED CORE WIRE BECOMES TAPERED. THIS RESULT WAS CONSIDERED TO BE SIMILAR TO THE CONDITION OF THE FRACTURE OF THE FRAGMENT. WHEN CONTINUOUS TORQUE FORCE IS APPLIED IN THE SAME DIRECTION TO A GUIDEWIRE IN STRAIGHT STATE, SPIRAL PATTERN STARTING FROM THE CENTER IS GENERATED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. WHEN REPEATED BENDING FORCE IS APPLIED TO A GUIDEWIRE WHILE ITS DISTAL END IS IN TRAPPED STATE, THE END OF FRACTURED CORE WIRE BECOMES FLAT, NO TAPERING IS OBSERVED ON THE SIDE, A DIMPLE PATTERN (HOLELIKE PATTERN) IS OBSERVED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. WHEN TENSILE FORCE IS APPLIED TO A GUIDEWIRE WHILE ITS SHAFT IS LOOPED AND ITS DISTAL END IN TRAPPED STATE, THE SIDE OF FRACTURE END BECOMES CURVED AND TAPERED. ROUGHNESS IS OBSERVED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. 4. CAUSE OF OCCURRENCE/CONCLUSION: [FRACTURE OF THE MAIN BODY]. IT WAS INFERRED THAT THE ACTUAL SAMPLE IN A CURVED STATE WAS EXPOSED TO CONTINUOUS TORQUE FORCE AND FRACTURED DUE TO METAL FATIGUE. [FRACTURE OF THE FRAGMENT]: IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS EXPOSED TO TENSILE FORCE WHILE A HARD OBJECT WAS IN CONTACT WITH THE AREA NEAR THE FRACTURE POINT, WHICH RESULTED IN THE FRACTURE. IT WAS PRESUMED THAT THERE WAS SOME PORTION MISSING FROM THE ACTUAL SAMPLE BECAUSE THERE WAS DIFFERENCE IN THE CONDITION OF FRACTURE SURFACE BETWEEN THE FRAGMENT AND THE MAIN BODY. RELEVANT INSTRUCTIONS FOR USE (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." 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 GUIDEWIRE WAS USED FOR ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP). THE GUIDEWIRE WAS INSERTED WHEN AN ENDOSCOPE WAS INTUBATED. IN SELECTING A BRANCH, THE GUIDEWIRE WAS TORQUED. AFTER CONFIRMING THAT THE DISTAL END CEASED SUDDENLY FROM RESPONDING, THEY REMOVED THE GUIDEWIRE AND FOUND THAT THE DISTAL END HAD BEEN FRACTURED. THE PROCEDURE WAS CONTINUED WITH A NEW PRODUCT AND FINISHED SUCCESSFULLY. WHEN THE ENDOSCOPE WAS REMOVED POST PROCEDURE, IT WAS FOUND THAT THE FRACTURED PIECE WAS REMAINING INSIDE. NO REMNANT IN THE PATIENT'S BODY. NO FRACTURED PIECE WAS IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976122 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A 230427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R