BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 11862635 · Received May 21, 2021

    Report

    Report Number
    9681834-2021-00081
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. LOT NUMBER: REQUESTED, NOT PROVIDED. 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. 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 SHIPPING INSPECTION RECORDS. A REVIEW OF DHF CONFIRMED THAT THE COATING MATERIAL OF RADIFOCUS GUIDEWIRE M IS IN COMPLIANCE WITH THE BIOLOGICAL SAFETY TEST SPECIFIED IN ISO. REGARDING RADIFOCUS GUIDEWIRE M, A REVIEW OF THE INFORMATION FROM THE MARKET FOR THE PAST THREE YEARS CONFIRMED THAT THERE WAS NO CASE IN WHICH THE COATING AGENT AFFECTED THE HUMAN BODY RESULTING IN ANAPHYLACTIC SHOCK. AS FOR THE EFFECTS OF THE COATING AGENT ON THE HUMAN BODY, THE CAUSAL RELATIONSHIP COULD NOT BE CLARIFIED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. ANAPHYLACTIC SHOCK OCCURRED WHEN EVER WAS IMPLEMENTED. THE USER IS INVESTIGATING WHETHER THE CAUSE IS IN THE MATERIALS USED AT THAT TIME. THEY ARE ALSO CONSIDERING THE POSSIBILITY OF THE COATING OF THE RADIFOCUS GUIDEWIRE. THERE WAS AN ANAPHYLACTIC SHOCK, HOWEVER THE PATIENT HAS SINCE RECOVERED AND IS STABLE. THOUGH THERE WAS A HEALTH HAZARD, IT WAS NOT SERIOUS. THE PATIENT HAS RECOVERED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761015 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1