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 2020-01-24 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[176232646]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176232647]
The patient had their great saphenous vein (gsv) and short saphenous vein (ssv) treated with vena seal. Procedure was carried out over 4 days as per ifu. 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. It was reported that the irritation is still present.
Patient Sequence No: 1, Text Type: D, B5
[182472330]
Additional information: the first vessel treated was the right anterior accessory great saphenous vein. The following day the left great anterior left saphenous vein was treated. The left great saphenous vein was treated 5 days later and the right great saphenous vein was treated one week after the first venaseal implant. The symptoms appeared on the day of the last procedure. The patient condition has resolved after treatment. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182473914]
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
[188465556]
Product analysis #(b)(6):-10 seven photographic images were received for evaluation. The first four images are of the consent form dated 01-07-2020 and include the venaseal peel-off label of lot 56818. The fifth, sixth, and seventh images are from a later date. The images are of red rash on the patient? S upper front thighs, upper arms, and obliques. Technical analysis of the received photographic images confirm the reported event of redness and rash over portions of the patient. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00401 |
| MDR Report Key | 9626959 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-01-24 |
| 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 | 2020-01-24 |
| 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 | 2020-01-24 |