VENA SEAL CLOSURE SYSTEM SP-101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.

Event Text Entries

[181548363] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[181548364] It is reported out of 1365 patients and 2595 treated veins, 19 patients have had an lymph fistula (0. 73%). In 19 cases, the fistula was opened and cleaned then they healed without complications in all described cases. Physician reported event as not a complication but just as a side effect which occurs with every surgery treatment in a ratio of 2-3 % and it is not deemed to be related to venaseal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-00953
MDR Report Key9773860
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-02
Date of Report2020-03-30
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-02
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 Received2020-03-02
Catalog NumberSP-101
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 2020-03-02

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