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 2020-03-23 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[184432982]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184432983]
A veneseal closure system was used during a procedure to treat the short saphenous vein (ssv), under local anesthesia. The device was not reprocessed, and the lumen was not flushed prior to use. The ifu was followed before, during and after the procedure. Tumescent infiltration was not utilised. Five segments were treated, and the vein was closed. Compression was used, which the patient was required to wear post procedure. Deep vein thrombosis was present at follow up in the ssv. It is reported that the patient is alive, with injury, with pain in the posterior tibial. The patient was prescribed anticoagulants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01269 |
| MDR Report Key | 9864321 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Model Number | VS-402 |
| Catalog Number | VS-402 |
| Lot Number | 57595 |
| 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 | 2020-03-23 |