BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 10017303 · Received May 1, 2020

    Report

    Report Number
    9681834-2020-00072
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 21, 2020
    Report Date
    May 1, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 . THIS REPORTED EVENT HAS BEEN DEEMED NOT REPORTABLE BASED OFF THE INSPECTION OF THE ACTUAL SAMPLE. THE DEVICE INVOLVED IN THIS COMPLAINT HAS BEEN VERIFIED TO BE THE NORMAL PRODUCT; THEREFORE, IS NOT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K122590, K163004. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A BUMP WAS RECOGNIZED ON THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE DURING PREPARATION, IT WAS VISIBLE AND TACTILE. THERE WAS NO PATIENT INVOLVED, EVENT OCCURRED PRE-TREATMENT. THE GW WAS NOT USED. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 24APR2020. THE EVENT DID NOT SIGNIFICANTLY DELAY THE PROCEDURE. THE DEVICE WAS REPLACED BY ANOTHER GLIDEWIRE ADVANTAGE. FOLLOWING THE EVENT, THE PATIENT WAS TREATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482902 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 191105

    Patients

    Seq Age Sex Outcome Treatment
    1