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 2020-01-14 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[175033840]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175033841]
During procedure, physician used venaseal occluding device to treat the great saphenous vein (gsv). The ifu was followed during preparation, procedure and post procedure. A guide wire was used for the insertion of the catheter. It was reported that post procedure (time frame unknown), patient returned with body rash. Patient was treated with steroid and recovered 3 to 4 weeks later. Four months later, patient returned on crutches with pain in leg and hurts to walk. Scan showed vein closed and no dvt. It is reported that the injury is possibly not vein related. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188388001]
Additional information: patients right great saphenous vein (gsv) was treated. Rash has resolved and is not present currently. No additional vein treatment has been given. Patient underwent an mri scan which has confirmed meniscus is partially torn in right knee. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00218 |
| MDR Report Key | 9587070 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| 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 | 2020-01-14 |