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 2020-03-26 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[185919500]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185919501]
A veneseal closure system was used during a procedure to treat the great saphenous vein (gsv). The device was not reprocessed. The lumen was not flushed prior to use. The ifu was followed before, during and after the procedure. No tumescent infiltration or compression was utilised. Local anesthesia was used. The vein was successfully closed. It is stated that the patient had complications post procedure. Seven days post-op, the patient developed a red itchy rash in the treatment zone. The patient had no signs or symptoms of an infection, and was asked to take nsaids and oral steroids. The patient returned with minimal resolution of symptoms and minor involvement of hives on abdomen. The patient was started on a non-tapering dose of prednisone and an antibiotic, as a precautionary measure. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01364 |
| MDR Report Key | 9883916 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-26 |
| 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 Country | IE |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | MEDTRONIC IRELAND |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Country | IE |
| 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 | 2020-03-26 |
| Catalog Number | VS-402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC IRELAND |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |