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 2020-03-23 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[184432982] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184432983] A veneseal closure system was used during a procedure to treat the short saphenous vein (ssv), under local anesthesia. The device was not reprocessed, and the lumen was not flushed prior to use. The ifu was followed before, during and after the procedure. Tumescent infiltration was not utilised. Five segments were treated, and the vein was closed. Compression was used, which the patient was required to wear post procedure. Deep vein thrombosis was present at follow up in the ssv. It is reported that the patient is alive, with injury, with pain in the posterior tibial. The patient was prescribed anticoagulants.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-01269
MDR Report Key9864321
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-25
Date of Event2020-03-11
Date Mfgr Received2020-03-23
Device Manufacturer Date2019-11-14
Date Added to Maude2020-03-23
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 Received2020-03-23
Model NumberVS-402
Catalog NumberVS-402
Lot Number57595
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 2020-03-23

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