BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 12039527 · Received June 22, 2021

    Report

    Report Number
    9681834-2021-00112
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 22, 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

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K923607,K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. A RADIFOCUS GUIDEWIRE M (ACTUAL SAMPLE) AND A MTW ERCP CATHETER FROM AVIS (CATHETER) WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RADIFOCUS GUIDEWIRE M (ACTUAL SAMPLE) REVEALED THAT IT HAD BEEN FRACTURED AT APPROXIMATELY 141 MM FROM THE DISTAL END AND THE MAIN BODY WAS APPROXIMATELY 2459 MM IN LENGTH, WHICH WAS 2600 MM IN TOTAL. AS THE LENGTH OF A NORMAL PRODUCT IS 2600 MM, IT WAS MOST UNLIKELY THAT THERE WAS A PORTION MISSING FROM THE ACTUAL SAMPLE. MAGNIFYING INSPECTION FOUND THAT BOTH FRACTURED ENDS OF THE OUTER LAYER HAD BEEN TAPERED AND THE CORE WIRE WAS EXPOSED. ELECTRON MICROSCOPIC INSPECTION FOUND CREASES ON THE OUTER LAYER OF BOTH FRACTURED ENDS. THE OUTER DIAMETER WAS MEASURED IN THE VICINITY OF THE FRACTURE ENDS AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY IN THE OUTER DIAMETER WAS OBSERVED. THE OUTER LAYER WAS DISSOLVED TO EXPOSE CORE WIRE. ELECTRON MICROSCOPIC INSPECTION REVEALED THAT BOTH ENDS WERE STRAIGHT AND NOT TAPERED WHEN SEEN FROM LATERAL SIDE. RADIAL PATTERN WAS OBSERVED ON THE FRACTURE SURFACE OF BOTH PORTIONS. INSPECTION OF THE MTW ERCP CATHETER FROM AVIS (CATHETER): VISUAL INSPECTION OF THE CATHETER FOUND NO KINK OR OTHER ANOMALY. MAGNIFYING INSPECTION OF THE CATHETER FOUND NO RIP OF OTHER ANOMALY. MECHANISM OF THE GUIDEWIRE FRACTURE: ONE-WAY TORQUE LOAD TO A TEST SAMPLE KEPT IN A CURVED SHAPE. THE FRACTURE END OF CORE WIRE IS STRAIGHT AND NOT TAPERED, AND RADIAL PATTERN IS OBSERVED ON THE FRACTURE SURFACE. THIS STATE IS SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE. REPEATED 90-DEGREE BENDING LOAD. THE FRACTURE END OF THE CORE WIRE IS NO TAPERED AND DIMPLE PATTERN IS OBSERVED ON THE FRACTURE SURFACE. IT WAS PRESUMED THAT THE ACTUAL SAMPLE HAD NOT BEEN FRACTURE DUE TO THIS MECHANISM. PULLING LOAD IN ONE DIRECTION. THE FRACTURE END OF THE CORE WIRE HAS BEEN TAPERED. IT WAS PRESUMED THAT THE ACTUAL SAMPLE HAD NOT BEEN FRACTURE DUE TO THIS MECHANISM. PULLING LOAD TO THE TEST SAMPLE KEPT IN A LOOP SHAPE. THE FRACTURE END OF THE CORE WIRE HAS BEEN TAPERED AND CURVED. IT WAS PRESUMED THAT THE ACTUAL SAMPLE HAD NOT BEEN FRACTURE DUE TO THIS MECHANISM. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE M 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. IT WAS LIKELY THAT THE CORE WIRE OF THE ACTUAL SAMPLE WAS FRACTURED DUE TO METAL FATIGUE CAUSED BY CONTINUOUS TORQUE OPERATION WHILE THE GUIDE WIRE WAS BENT. AFTER THAT, IT WAS THOUGHT THAT THE OUTER LAYER WAS TORN OFF AND SEPARATED DUE TO THE LOAD DURING REMOVAL. SINCE THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS CONFIRMED TO BE THE SAME AS THAT OF THE NORMAL PRODUCT, IT WAS LIKELY THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. AS FOR THE CATHETER, IT WAS CONSIDERED NOT TO BE INVOLVED IN THIS ISSUE, BASED ON THE MECHANISM POSSIBLY LEADING TO THE FRACTURE OF 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 · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE WAS USED IN COMBINATION WITH MTW ERCP CATHETER (FROM AVIS) FOR ENBD TUBING PLACEMENT. AFTER ABOUT THIRTY MINUTES OF INTRAOPERATIVE USE, THE ANGLE OF THE GUIDEWIRE STOPPED FUNCTIONING, AND THE GUIDEWIRE WAS FOUND FRACTURED. THE FRACTURED PART WAS RETRIEVED. THE MTW ERCP CATHETER IS A REUSABLE PRODUCT. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942843 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention