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 2020-01-30 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[177150506]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177150507]
The patient had their right anterior accessory great saphenous vein (rt aagsv) , left anterior accessory great saphenous vein (lt aagsv), left great saphenous vein (lt gsv) and right great saphenous vein (rt gsv) treated with vena seal. Procedure was carried as per ifu. The first vessel treated was the rt aagsv. The following day the lt aagsv was treated. Lt gsv was treated 5 days later and the rt gsv was treated one week after the first venaseal implant. Post-procedure a skin irritation was reported on the patient? S back and neck. The patient was treated with a medrol dose pack, topical steroid, antihistamines. No further injury was reported to this event. The patient condition has resolved after treatment.
Patient Sequence No: 1, Text Type: D, B5
[182473863]
Image review: seven photographic images were received for evaluation. The images are of red rash on the patient? S upper front thighs, upper arms, and obliques. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00472 |
| MDR Report Key | 9646067 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-01-30 |
| 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 | 2020-01-30 |
| Model Number | VS-402 |
| Catalog Number | VS-402 |
| Lot Number | 56818 |
| 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 | 2020-01-30 |