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 2020-02-10 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.

Event Text Entries

[178320976] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[178320977] Physician used venaseal occluding device to treat the patient's entire great saphenous vein (gsv). Ifu was followed. A guide wire was used for the insertion of the catheter. It was reported that at patient follow up approximately 7 weeks post procedure, a granuloma was observed. The granuloma has been removed in a new procedure with venaseal. There was no further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[188591282] Additional information: during index procedure, local anesthesia was used and compression was performed with the transducer. The catheter tip was located 5cm caudal to the saphenofemoral junction (sfj) prior to initial delivery of adhesive. The venaseal procedure was completed without issue and the vein closed. The granuloma was removed through a small incision in a separate procedure. No additional venaseal treatment was performed as was originally reported. The patient is doing well. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188592460] Additional information: the pathology report confirms the presence of non-malignant fibrinoid material in the excised granuloma. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188592722] 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 Number9612164-2020-00633
MDR Report Key9686205
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-10
Date of Report2020-03-12
Date of Event2020-02-06
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-05-22
Date Added to Maude2020-02-10
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 Received2020-02-10
Catalog NumberSP-101
Lot Number55792
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 2020-02-10

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