VENA SEAL CLOSURE SYSTEM VS-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-07 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[178110182] Image review: a sonogram was received for review. The image confirms material in the common femoral vein (cfv) extending from the junction which appears to occupy approximately 50% of the cfv lumen. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[178110183] Patient had great saphenous vein (gsv) treated with venaseal. One segment was treated. One-week post procedure. It is reported there is glue in the junction. The patient is reported to be alive without injury.
Patient Sequence No: 1, Text Type: D, B5


[188590091] Additional information: ifu was followed. The catheter was located 5cm distal to the saphenofemoral junction prior to initial delivery of adhesive. Patient was prescribed prednisone. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612164-2020-00604
MDR Report Key9680331
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-07
Date of Report2020-02-12
Date of Event2019-11-21
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer Phone091708734
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENA SEAL CLOSURE SYSTEM
Generic NameAGENT, OCCLUDING, VASCULAR, PERMANENT
Product CodePJQ
Date Received2020-02-07
Catalog NumberVS-402
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-02-07

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