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 2020-02-07 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[178110182]
Image review: a sonogram was received for review. The image confirms material in the common femoral vein (cfv) extending from the junction which appears to occupy approximately 50% of the cfv lumen. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178110183]
Patient had great saphenous vein (gsv) treated with venaseal. One segment was treated. One-week post procedure. It is reported there is glue in the junction. The patient is reported to be alive without injury.
Patient Sequence No: 1, Text Type: D, B5
[188590091]
Additional information: ifu was followed. The catheter was located 5cm distal to the saphenofemoral junction prior to initial delivery of adhesive. Patient was prescribed prednisone. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00604 |
| MDR Report Key | 9680331 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-07 |
| 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. Other; 2. Required No Informationntervention | 2020-02-07 |