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 2020-01-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[182395241]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182395242]
Patient had short saphenous vein treated with venaseal. Procedure completed successfully and the vein is reported to have closed. It is reported the patient developed a foreign body reaction described as a? Venaseal cap? Comprising of a white pimple with redness around the area approximately 5 months post procedure in the right small saphenous vein. The physician performed a debridement procedure to remove and found it to be grainy/granular venaseal material. The patient was administered antibiotics (augmentin, levaquin and bacitracin). The wound is reported to be slowly healing.
Patient Sequence No: 1, Text Type: D, B5
[188281589]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188281597]
Additional information update: patient had right short saphenous vein treated with venaseal for 20 centimeters with 1. 0 cc adhesive administered. There was no difficulties noted to the location of the catheter tip prior to the initial delivery of adhesive. The catheter tip was 5 cm caudal to the sfj. The patient is still recovering and well. The wound is expected to be healed in 2 weeks. Index procedure date and symptoms onset date were provided. Event occurred 2 months post procedure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9612164-2020-00023 |
MDR Report Key | 9537714 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-01-02 |
Date of Report | 2020-03-24 |
Date of Event | 2019-09-18 |
Date Mfgr Received | 2020-03-23 |
Date Added to Maude | 2020-01-02 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | TONI O'DOHERTY |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Manufacturer Phone | 091708734 |
Manufacturer G1 | MEDTRONIC IRELAND |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VENA SEAL CLOSURE SYSTEM |
Generic Name | AGENT, OCCLUDING, VASCULAR, PERMANENT |
Product Code | PJQ |
Date Received | 2020-01-02 |
Catalog Number | VS-402 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC IRELAND |
Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-01-02 |