BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELANO VASCULAR Q2 EXTENSION SET

    MDR report key: 9221672 · Received October 22, 2019

    Report

    Report Number
    1649914-2019-00052
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    FPA
    PMA / PMN Number
    K182897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES RELATED TO THE REPORTED COMPLAINT CONDITION WAS FOUND. THE DEVICE WAS EVALUATED AND THE REPORTED COMPLAINT CONDITION COULD NOT DUPLICATED. THE SUSPECTED ROOT CAUSE OF THIS INCIDENT IS FAILURE OF THE USER TO FULLY ENGAGE THE CLAMP . QUEST WILL CONTINUE TO MONITOR TRENDS FOR THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE REPORT RECEIVED STATES THAT DURING USE OF THE DEVICE IN A CTA PE STUDY, THE CLAMP CAME OFF, SPRAYING CONTRAST ALL OVER THE PATIENT. THE PROCEDURE HAD TO BE REDONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015697 VELANO VASCULAR Q2 EXTENSION SET IV EXTENSION SETS FPA QUEST MEDICAL, INC 95906BNS 058056 OR 058115

    Patients

    Seq Age Sex Outcome Treatment
    1