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 2020-03-09 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[182611663]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182611664]
Physician used venaseal occlusion during procedure to treat a segment in the great saphenous vein (gsv). Ifu was followed. It was reported that patient got an infection after a venaseal procedure. Patient was prepped in a sterile fashion for rf ablation. The rf generator failed pre insertion of any catheter and therefore rf ablation was not attempted. Patient was re-prepped in a sterile fashion and venaseal procedure was done per protocol using sterile technique with no immediate complications. Patient presented with fevers, chills, cellulitis and (b)(6) bacteremia 3 days post implant. Patient had endovascular venous infection, the entire vein had to be extracted and pus was seen coming out of the vein. The wound was left open. 4 weeks of iv antibiotics was initiated for endovascular infection. The patient had the vein stripped out. No further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01066 |
| MDR Report Key | 9804847 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-04-25 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| Catalog Number | VS-402 |
| Lot Number | 55489 |
| 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 | 2020-03-09 |