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 2019-12-23 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.

Event Text Entries

[176412958] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[176412959] Physician used venaseal occluding device during procedure to treat 15cm of the great saphenous vein (gsv). Ifu was followed during preparation, procedure and post procedure. A guide wire was used for the insertion of the catheter. It was reported that the bilateral venaseal scheduled for the patient, tor the treatment of the left gsv was done with no issues observed. Glue catheter was removed from left leg, tip was wiped clean with a clean dry gauze. Same catheter was used for right gsv. When administering the 1st dose 6cm away from the sfj, plunger in the syringe did not move, although gun leaver was pressed firmly and held for 3 secs. Compression was maintained with an ultrasound transducer. Physician repeatedly administered 2 more doses at the same spot but, plunger did not move. A new kit from the same lot was opened. The procedure was completed with a gun and syringe of glue per ifu. 30 - 35 minutes post-procedure ultrasound scan showed that cfv near the sfj was 20% occluded with 0. 3mls glue, about 1 cm long segment. The procedure was converted from endo to open procedure to remove hardened glue from cfv near the sfj. No further patient injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5


[181860604] Post procedure ultrasound scan was carried out 30 - 45 minutes 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 Number9612164-2019-05286
MDR Report Key9509182
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-23
Date of Report2019-12-27
Date of Event2019-12-16
Date Mfgr Received2019-12-23
Device Manufacturer Date2019-05-07
Date Added to Maude2019-12-23
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 Received2019-12-23
Model NumberSP-101
Catalog NumberSP-101
Lot Number55676
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 2019-12-23

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