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 2019-12-16 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[175237620] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[175237621] Physician used a venaseal kit during treatment of the patient? S great saphenous vein (gsv). Ifu was followed. A guidewire was used for insertion of the catheter. It is reported that midway through the procedure the gun could no longer dispense glue. The procedure is reported to be partially completed. It is unknown if additional treatment was required. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[188148127] Product analysis: components (dispenser gun, catheter and one syringe) were returned for analysis. No damage noted on the gun. A 3ml syringer was inserted with the plunger pulled back during each functional test. Due to dried glue residue in the gun interior, the plunger was only able to be pulled back to 2. 8 ml instead of 3 ml. The plunger failed to advance to the end of the syringe during three trigger tests, but after tightening the screws of the dispensing gun, the responsiveness of the trigger pulls was improved. 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 Number9612164-2019-05182
MDR Report Key9472948
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-16
Date of Report2020-02-17
Date of Event2019-12-11
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-02-12
Date Added to Maude2019-12-16
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 Received2019-12-16
Returned To Mfg2020-01-02
Catalog NumberVS-402
Lot Number54696
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-16

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