BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE EVLT SPOTLIGHT OPS

    MDR report key: 3190777 · Received June 14, 2013

    Report

    Report Number
    1319211-2013-00079
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT DUE TO THIS EVENT. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(4) 2013, A PT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. DURING THE PROCEDURE, THE TREATING PHYSICIAN NOTED THE GUIDEWIRE UNWRAPPED WHILE ADVANCING INTO THE SHEATH. THE DEVICE WAS REMOVED AND SET ASIDE. A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272362 VENACURE EVLT SPOTLIGHT OPS ENDOVENOUS LASER TREATMENT FIBER GEX

    Patients

    Seq Age Sex Outcome Treatment
    1