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 2020-02-24 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[180635905] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[180635906] Physician used a venaseal occluding device during procedure to treat the great saphenous vein (gsv). The lumen was flushed prior to use. Ifu was followed. A guide wire was used for the insertion of the catheter. It was reported that post procedure, patient reported access site issues with irritation, drainage and discoloration. Patient reportedly has a healed access site wound at this time. It was advised to debride the access site for a glue remnant if symptoms re-appear. Antibiotics were prescribed during the initial phase and post procedure. Patient is in follow-up phase with a healed access site wound, which had previously been irritated with drainage and discoloration. No further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[188748917] Additional information: venaseal treatment was performed in one limb only. The catheter tip was located 5cm caudal to the great saphenous vein prior to initial delivery of adhesive. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188749184] Additional information: the patient had a hypersensitivity reaction within 24 hours of her initial treatment. About three and half months later, the patient went to the hospital after experiencing a 102? F fever and not alerting the facility over the weekend. The physician noticed the patient has terrible cellulitis and needed an iv antibiotic. The patient was sent to a hospital and was prescribed rocephin and vanco. The patient is currently hospitalized. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188749252] 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 Number9612164-2020-00852
MDR Report Key9744779
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-24
Date of Report2020-03-31
Date of Event2019-11-05
Date Mfgr Received2020-03-26
Date Added to Maude2020-02-24
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 Received2020-02-24
Catalog NumberVS-402
Lot NumberUNK
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. Hospitalization; 2. Required No Informationntervention 2020-02-24

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