BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11460018 · Received March 11, 2021

    Report

    Report Number
    9681834-2021-00021
    Event Type
    Death
    Date Received
    March 11, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 11, 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

    DATE OF PATIENT DEATH IS UNKNOWN. 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)- K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORDS. THE COATING AGENT FOR RADIFOCUS GUIDE WIRE M WAS CONFIRMED TO HAVE PASSED THE BIOLOGICAL SAFETY TEST SPECIFIED IN ISO. THE COMPLAINT RECORD ABOUT RADIFOCUS GUIDEWIRE M FOR THE LAST THREE YEARS WAS REVIEWED. IT WAS CONFIRMED THAT THERE WERE NOT ANY REPORTS ON ANY CASES WHERE THE COATING AGENT CAME OFF FROM THE PRODUCT AND CEREBRAL INFARCTION OR CEREBRAL EDEMA OCCURRED. THE COATING AGENT USED FOR RADIFOCUS GUIDEWIRE M COMPLIES WITH THE BIOLOGICAL SAFETY TESTS SPECIFIED IN THE ISO STANDARD, AND THE HOMOGENEITY OF THE COATING STATE IS ASSURED THROUGH THE REGULAR TESTS AND LOT MANAGEMENT. IN ADDITION TO RADIFOCUS GUIDEWIRE M, ABOUT ALL ASHITAKA-MADE PRODUCTS WITH THE COATING, SUCH THE OTHER GUIDEWIRES AS WELL AS THE CATHETERS, THE COATING AGENT USED FOR THEM COMPLIES WITH THE BIOLOGICAL SAFETY TESTS SPECIFIED IN THE ISO STANDARD, AND THE HOMOGENEITY OF THE COATING STATE IS ASSURED THROUGH REGULAR TESTS AND LOT MANAGEMENT. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. NO SIMILAR CASE WAS FOUND IN THE COMPLAINT RECORD, AND THE CAUSAL LINK BETWEEN THE PEELING OF COATING AGENT AND ITS INFLUENCE ON THE HUMAN BODY COULD NOT BE CONFIRMED FROM THE INVESTIGATION RESULT. 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 INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. AFTER CAROTID ARTERY STENTING, THE PATIENT SUFFERED CEREBRAL INFARCTION AND DIED. THE DOCTOR SEEMED TO HAVE DOUBT ABOUT THE CAUSE OF THE PATIENT DEATH BECAUSE THE OPERATION WENT FAVORABLE AND TOOK 46 MINUTES ONLY TO COMPLETE. HE IS CONSULTING MULTIPLE CEREBROVASCULAR TREATMENT PRECEPTORS OUTSIDE THE INVOLVED FACILITY, LISTING THE POSSIBLE CAUSES OF THE CEREBRAL INFARCTION AND INVESTIGATING ONE BY ONE. DURING THE INVESTIGATION, HE RECEIVED AN OPINION THAT THE COATING AGENT MIGHT HAVE COME OFF THE CATHETER (OR GUIDE WIRE) PLACED IN THE SKULL, OR THAT METAL ALLERGIES MIGHT HAVE OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AS THE PATIENT DIED, ALL THE DEVICES USED IN THIS CASE ARE UNDER THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363464 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ASAHI FUBUKI AIN-FBK-8SR.| CAROTID WALLSTENT 39150-1024.| FILTER WIRE EZ 39142-190.| MEDIKIT ANGIOGRAPHIC CATHETER SZ4244.| STERLING MR 39031-30401.| STERLING MR 39031-45401.