BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 17622793 · Received August 25, 2023

    Report

    Report Number
    9681834-2023-00171
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3: PATIENT SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: PMA/510(K): K926214. 1. INSPECTION OF THE ACTUAL SAMPLE: THE MAIN BODY AND THE FRAGMENT WERE RETURNED. 1.1. VISUAL INSPECTION OF THE ACTUAL SAMPLE: LENGTH OF THE FRAGMENT: APPROXIMATELY 142 MM. LENGTH OF THE MAIN BODY OF THE ACTUAL SAMPLE: APPROXIMATELY 2458 MM. TOTAL LENGTH: 2600 MM. SINCE THE SPECIFIED LENGTH OF THIS PRODUCT IS 2600 MM, IT WAS ASSUMED THAT NO PORTION WAS MISSING FROM THE ACTUAL SAMPLE. 1.2. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE: THE CORE WIRE WAS EXPOSED AT THE FRACTURE SITE OF THE FRAGMENT. THE FRAGMENT AND THE MAIN BODY WERE FOUND MATCHED WITH EACH OTHER IN TERMS OF THE SHAPE OF FRACTURED OUTER LAYER. NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. 1.3. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE: WRINKLES WERE OBSERVED IN THE OUTER LAYER OF BOTH PORTIONS. THE FRACTURE SITE OF OUTER LAYER OF BOTH PORTIONS SHOWED A SHREDDED-LIKE SHAPE. 1.4. DIMENSIONS OF THE ACTUAL SAMPLE: OUTER DIAMETER (UNDAMAGED AREA NEAR THE FRACTURE): IT WAS WITHIN THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. 1.5. ELECTRON MICROSCOPIC INSPECTION: THE OUTER LAYER WAS REMOVED, AND THE CORE WIRE AT THE FRACTURE SITE WAS SUBJECTED TO AN ELECTRON MICROSCOPIC INSPECTION. THE SIDES OF BOTH PORTIONS WERE NOT TAPERED BUT FLAT. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF BOTH PORTIONS. 2. HISTORY INVESTIGATION OF THE PRODUCT WITH 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 WAS REGULARITY IN THE CONDITION OF CORE WIRE DEPENDING ON THE MECHANISM LEADING TO THE FRACTURE. 3.1. WHEN CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION TO A CURVED GUIDEWIRE, THE FRACTURE END OF CORE WIRE BECAME FLAT, NO TAPERING WAS OBSERVED ON THE SIDE, AND RADIAL PATTERN WAS GENERATED ON THE FRACTURE SURFACE. FROM THIS, THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED TO BE SIMILAR TO THIS STATE. 3.2. WHEN CONTINUOUS TORQUE FORCE WAS APPLIED IN THE SAME DIRECTION TO A GUIDEWIRE IN STRAIGHT STATE, SPIRAL PATTERN STARTING FROM THE CENTER WAS GENERATED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. 3.3. WHEN REPEATED BENDING FORCE WAS APPLIED TO A GUIDEWIRE WHILE ITS DISTAL END WAS IN TRAPPED STATE, THE FRACTURE END OF CORE WIRE BECAME FLAT, NO TAPERING WAS OBSERVED ON THE SIDE, A DIMPLE PATTERN (A HOLE-LIKE PATTERN) WAS OBSERVED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. 3.4. WHEN TENSILE FORCE WAS APPLIED TO A GUIDEWIRE WHILE ITS DISTAL END WAS IN TRAPPED STATE, THE SIDE OF FRACTURE END BECAME TAPERED, THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. 3.5. WHEN TENSILE FORCE WAS APPLIED TO A GUIDEWIRE WHILE ITS SHAFT WAS LOOPED AND ITS DISTAL END IN TRAPPED STATE, THE SIDE OF FRACTURE END BECAME CURVED AND TAPERED. ROUGHNESS WAS OBSERVED ON THE FRACTURE SURFACE. THE STATE OF THE ACTUAL SAMPLE WAS CONSIDERED DIFFERENT FROM THIS STATE. 4. CAUSE OF OCCURRENCE/CONCLUSION: IT WAS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO REPETITIVE TORQUE FORCE, LEADING TO THE FRACTURE OF CORE WIRE AT APPROXIMATELY 142 MM FROM THE DISTAL END DUE TO METAL FATIGUE. AFTER THAT, IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS EXPOSED TO PULLING FORCE DURING WITHDRAWAL AND THE OUTER LAYER WAS TORN OFF, WHICH RESULTED IN THE COMPLETE BREAKAGE INTO TWO PORTIONS INSIDE THE PATIENT BODY. SINCE THE TOTAL LENGTH OF ACTUAL SAMPLE INCLUDING THE FRACTURED FRAGMENT WAS EQUIVALENT TO THAT OF THE NORMAL PRODUCT, IT WAS LIKELY THAT THERE WAS NO MISSING PART. 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 THEY HAD A RETRIEVAL FROM ENDOSCOPIC PORT. DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING MTW (ABIS) IN THE ENDOSCOPY ROOM, WHEN THE PHYSICIAN ATTEMPTED TO INSERT A GUIDEWIRE INTO THE PANCREATIC DUCT HE FELT RESISTANCE, SO PULLED IT OUT AND FOUND THAT IT HAD BEEN CUT OFF IN THE MIDDLE. HE HAD PUSHED AND PULLED THE GUIDEWIRE SEVERAL TIMES WHILE APPLYING TORQUE FORCE SINCE THE INSERTION WAS DIFFICULT. THE MTW TUBE USED DURING THE EVENT IS A PRODUCT MADE OF SILICONE, BUT THERE IS A METAL-LIKE SUBSTANCE INSIDE THE TUBE. THE ENTIRE MTW WAS REMOVED FROM THE ENDOSCOPE AND RECOVERED. THE PROCEDURE OUTCOME WAS NOT REPORTED. NO FRACTURED PIECE REMAINED IN THE PATIENT'S BODY AS IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815510 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 221219YA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown