BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, EVH

    MDR report key: 4837703 · Received June 9, 2015

    Report

    Report Number
    1124841-2015-00185
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS - AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JUNE 9, 2015. ADDITIONAL EVENT INFORMATION OBTAINED FROM THE USER FACILITY REVEALED THAT THE EVH DID NOT CAUSE THE REPORTED EVENT; THEREFORE, NO TESTING METHODS WERE PERFORMED ON THE COMPLAINT DEVICE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT A ROUND, BLISTER-LIKE MARK WAS FOUND ON THE PATIENT'S LEG AFTER THE DRAPES WERE REMOVED AT THE END OF THE PROCEDURE. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS NOT DELAYED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY REVEALED THAT THE EVENT WAS DETERMINED NOT TO BE RELATED TO THE EVH PROCEDURE OR THE HARVESTER. IT IS THOUGHT TO BE RELATED TO AN ENVIRONMENTAL FACTOR SUCH AS THE DRAPE MATERIAL AND / OR THE SKIN PREP SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373161 VIRTUOSAPH PLUS, EVH GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. VSP550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other