BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 21293607 · Received February 3, 2025

    Report

    Report Number
    9681834-2025-00008
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    October 1, 2024
    Report Date
    February 3, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A3B: GENDER: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. 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. E2: HEALTH PROFESSIONAL: UNKNOWN. E3: OCCUPATION: UNKNOWN. G4: 510(K): K122590, K163004. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE REVIEWED. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, THE PAST COMPLAINT FILE COULD NOT BE INVESTIGATED. SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN, HISTORY INVESTIGATION COULD NOT BE PERFORMED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR 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. (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 A PENAL STONE REMOVAL PROCEDURE WAS COMPLETED TOLERABLY; HOWEVER, IT WAS NOTICED ON A FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN THAT AN ADVANTAGE WIRE COATING REMAINED EMBEDDED WITHIN THE PATIENT'S VESSEL. IT WAS ATTEMPTED TO REMOVE DURING A FURTHER STONE REMOVAL PROCEDURE; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT IT DID NOT CAUSE ANY ISSUES FOR THE PATIENT. THE COATING PEELED OFF INSIDE THE PATIENT BODY, AND ALTHOUGH MEDICAL INTERVENTION WAS PERFORMED TO REMOVE IT, IT REMAINED IN THE BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED; HOWEVER, THERE WAS SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190581 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RA*FA18301CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R