BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO RADIFOCUS GUIDE WIRE

    MDR report key: 21462482 · Received February 25, 2025

    Report

    Report Number
    9681834-2025-00017
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    January 24, 2025
    Report Date
    February 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
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOTE EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K): K926214. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, ITS CONDITION COULD NOT BE INVESTIGATED. A HISTORICAL INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER REVEALED NO ANOMALIES IN THE MANUFACTURING RECORD OR THE SHIPPING INSPECTION RECORD. CAUSE OF OCCURRENCE/CONCLUSION: SINCE NO ANOMALIES WERE FOUND IN THE MANUFACTURING HISTORY RECORD AND THE CONDITION OF THE ACTUAL SAMPLE COULD NOT BE INVESTIGATED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: WARNINGS IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, CEASE MANIPULATION OF THE GUIDE WIRE GT AND/OR THE CATHETER IMMEDIATELY. DETERMINE THE CAUSE USING FLUOROSCOPY. TERUMO MEDICAL CORPORATION (TMC) (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 DURING AN INFERIOR EPIGASTRIC EMBOLIZATION PROCEDURE, THERE WAS AN ISSUE WITH MOUNTING THE MICRO GUIDE DURING THE SECOND CATHETERIZATION OF THE MICRO CATHETER. THE MICRO GUIDE ROLLED UP AT THE START OF THE MICRO CATHETER. THE INTERVENTION WAS DELAYED. NO INJURY OR HARM WAS REPORTED. THE EVENT OCCURRED INTRA-OPERATIVELY. A SHEARED PIECE MAY REMAIN INSIDE THE PATIENT'S BODY. THE FINAL PATIENT IMPACT WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465318 TERUMO RADIFOCUS GUIDE WIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RG*GW1218SM 240723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R