BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23643678 · Received November 25, 2025

    Report

    Report Number
    9681834-2025-00217
    Event Type
    Death
    Date Received
    November 25, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 25, 2025
    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

    B2: DATE OF DEATH: UNKNOWN. D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . G4: 510(K) NUMBER: K923607, K926214. THE RETURNED DEVICE: ONLY THE MAIN PART OF THE GUIDEWIRE AND TORQUE DEVICE. APPEARANCE CONFIRMATION: THE WIRE STRAND HAD BEEN EXPOSED AT THE FRACTURED PART. A SHAPE THAT SEEMED TO BE TORN OFF WAS OBSERVED IN THE OUTER LAYER OF THE FRACTURED PART. THE OUTER LAYER HAD BEEN FLARED, FRACTURED AND ELONGATED AT APPROXIMATELY 780 MM FROM THE FRACTURED PART. AN ABRASION WAS OBSERVED AT APPROXIMATELY 1000MM FROM THE FRACTURED PART. NO ANOMALY SUCH AS ABRASION WAS FOUND IN APPEARANCE IN OTHER PARTS. APPEARANCE CONFIRMATION OF THE WIRE STRAND: NO TAPERING WAS OBSERVED ON THE SIDE OF THE WIRE STRAND AT THE FRACTURED PART. A RADIAL PATTERN WAS OBSERVED ON THE TOP SURFACE OF THE WIRE STRAND AT THE FRACTURED PART. DIMENSIONAL INSPECTION: THE OUTER DIAMETER (NORMAL PART): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. LENGTH OF MISSING PORTION: ACTUAL DEVICE: APPROXIMATELY 1655MM, CURRENT PRODUCTS: APPROXIMATELY 1800 MM. THE MISSING LENGTH WAS ESTIMATED TO BE APPROXIMATELY 145 MM. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR EVENT WAS FOUND IN THE PAST COMPLAINT FILE. SIMULATION TEST: IT WAS FRACTURED BY APPLYING CONTINUOUS TORQUE LOAD IN THE SAME DIRECTION WHILE IT WAS CURVED. NO TAPERING WAS OBSERVED ON THE SIDE OF THE WIRE STRAND AT THE FRACTURED PART. A RADIAL PATTERN WAS OBSERVED ON THE TOP SURFACE OF THE WIRE STRAND AT THE FRACTURED PART. IT WAS PUSHED AND PULLED WITH A RESIN TORQUE DEVICE FIXED TO THE GUIDEWIRE. THE WIRE STRAND WAS EXPOSED. THE OUTER LAYER WAS FRACTURED AND ELONGATED. THESE RESULTS SUGGEST THAT THE CONDITION IS ALL SIMILAR TO THAT OF THE ACTUAL DEVICE. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND DIMENSIONS OF THE ACTUAL DEVICE. BASED ON THE CONDITION OF THE ACTUAL DEVICE AND SIMULATION TEST, ONE POSSIBILITY FOR THIS CASE WAS THAT THE WIRE STRAND WAS FRACTURED WHEN A CONTINUOUS TORQUE LOAD WAS APPLIED IN THE SAME DIRECTION WHILE IT WAS BENT. SUBSEQUENTLY, WHEN THE ACTUAL DEVICE WAS REMOVED, A TENSILE LOAD WAS APPLIED TO THE ACTUAL DEVICE, CAUSING THE OUTER LAYER TO SEVER INSIDE THE BODY. ADDITIONALLY, IT WAS BELIEVED THAT THE FLARE AND ABRASION ON THE OUTER LAYER APPROXIMATELY 780 MM AND 1,000 MM FROM THE FRACTURED PART WERE CAUSED BY THE TORQUE DEVICE. FURTHERMORE, COMPARED TO THE CURRENT PRODUCT, THE ACTUAL DEVICE IS THOUGHT TO HAVE A MISSING PORTION OF APPROXIMATELY 145 MM. 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 CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. DURING TREATMENT FOR OCCLUSION OF THE SUPERIOR MESENTERIC ARTERY (SMA), FIBRINOLYTIC THERAPY (UROKINASE THROMBOLYSIS) WAS ATTEMPTED TO DISSOLVE THE THROMBUS; HOWEVER, IT WAS UNSUCCESSFUL. THE OCCLUDED LESION HAD A HARD SEGMENT, AND ATTEMPTS WERE MADE TO PASS THE WIRE THROUGH BY PUSHING AND ROTATING MANEUVERS. HOWEVER, THE WIRE FRACTURED. RETRIEVAL USING A SNARE WAS ATTEMPTED HOWEVER WAS NOT SUCCESSFUL, RESULTING IN THE WIRE REMAINING INSIDE THE BODY. THE POSSIBILITY THAT THE PATIENT'S DEATH WAS RELATED TO THE GUIDEWIRE CANNOT BE RULED OUT, AND IT MAY HAVE BEEN A CONTRIBUTING FACTOR. THE PROCEDURE WAS FINISHED ONCE, AND THE GUIDE WIRE REMAINING IN THE BODY WAS PLANNED TO BE REMOVED BY LAPAROTOMY AT A LATER DATE. THE PATIENT DIED OF THROMBOTIC OCCLUSION OF SMA. THE CAUSAL RELATIONSHIP WITH THE REMAINING GUIDEWIRE IN THE BODY WAS NOT 0; HOWEVER, IT WAS BELIEVED THAT IT DID NOT AFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2789620 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-PA35183 241205YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R| O