BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PLUS PRESSURE GUIDE WIRE 185CM

    MDR report key: 8585793 · Received May 7, 2019

    Report

    Report Number
    8585793
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 19, 2019
    Manufacturer
    VOLCARICA S.R.L.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOOKED UP VOLCANO VERRATA PRESSURE WIRE AND INSERTED INTO PATIENT. WIRE HAD ERRORS OF PRESSURE LIMITS AND NOT GIVING THE DOCTOR A PRESSURE TO COMPLETE THE STUDY. MANUFACTURER RESPONSE FOR PRESSURE WIRE, VOLCANO (PER SITE REPORTER). WILL PICK IT UP TO FIX IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381195 VERRATA PLUS PRESSURE GUIDE WIRE 185CM WIRE, GUIDE, CATHETER DQX VOLCARICA S.R.L. 10185P 0301613738

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA