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 2020-01-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[182395241] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182395242] Patient had short saphenous vein treated with venaseal. Procedure completed successfully and the vein is reported to have closed. It is reported the patient developed a foreign body reaction described as a? Venaseal cap? Comprising of a white pimple with redness around the area approximately 5 months post procedure in the right small saphenous vein. The physician performed a debridement procedure to remove and found it to be grainy/granular venaseal material. The patient was administered antibiotics (augmentin, levaquin and bacitracin). The wound is reported to be slowly healing.
Patient Sequence No: 1, Text Type: D, B5


[188281589] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188281597] Additional information update: patient had right short saphenous vein treated with venaseal for 20 centimeters with 1. 0 cc adhesive administered. There was no difficulties noted to the location of the catheter tip prior to the initial delivery of adhesive. The catheter tip was 5 cm caudal to the sfj. The patient is still recovering and well. The wound is expected to be healed in 2 weeks. Index procedure date and symptoms onset date were provided. Event occurred 2 months post procedure. 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 Number9612164-2020-00023
MDR Report Key9537714
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-02
Date of Report2020-03-24
Date of Event2019-09-18
Date Mfgr Received2020-03-23
Date Added to Maude2020-01-02
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 Received2020-01-02
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. Required No Informationntervention 2020-01-02

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