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 2020-01-30 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[177003104] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[177003105] The patient had their right anterior accessory great saphenous vein (rt aagsv) , left anterior accessory great saphenous vein (lt aagsv), left great saphenous vein (lt gsv) and right great saphenous vein (rt gsv) treated with vena seal. Procedure was carried as per ifu. The first vessel treated was the rt aagsv. The following day the lt aagsv was treated. Lt gsv was treated 5 days later and the rt gsv was treated one week after the first venaseal implant. Post-procedure a skin irritation was reported on the patient? S back and neck. The patient was treated with a medrol dose pack, topical steroid, antihistamines. No further injury was reported to this event. The patient condition has resolved after treatment.
Patient Sequence No: 1, Text Type: D, B5


[182473864] Image review: four photographic images were received for evaluation. The images are of red rash on the patient? S upper front thighs, upper arms, and obliques. Portions of the patient. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182473878] 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 Number9612164-2020-00471
MDR Report Key9646065
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-30
Date of Report2020-03-06
Date of Event2020-01-14
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-08-26
Date Added to Maude2020-01-30
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 Received2020-01-30
Model NumberVS-402
Catalog NumberVS-402
Lot Number56818
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. Required No Informationntervention 2020-01-30

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