MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-03 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.
[173714096]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173714097]
Physician used venaseal to treat patient? S great saphenous vein (gsv) and short saphenous vein (ssv) following recurrence of varicose veins after laser surgery. Ifu was followed. The vein is reported to have closed. It is reported one-week post implant the patient presented with an allergic reaction reported as redness and itching. Patient was prescribed anti-histamines and nsaids. Approximately 2 weeks later the patient presented with edema especially around the eye. The patient returned to the hospital 2 days after the edema occurring and has been given a steroid injection. Reaction appears as systemic allergic reaction post venaseal treatment.
Patient Sequence No: 1, Text Type: D, B5
[188284430]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188284784]
Additional information: the catheter was placed 5cm caudal to the saphenofemoral junction (sfj) prior to delivery of adhesive. Both left and right great saphenous vein (gsv) and short saphenous vein (ssv) were treated. No allergy patch test was performed prior to procedure. Patient's condition is not improving. Patient is returning to hospital often for treatment. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00061 |
| MDR Report Key | 9544704 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-04-17 |
| Date Added to Maude | 2020-01-03 |
| 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 | 2020-01-03 |
| Catalog Number | SP-101 |
| Lot Number | 55442 |
| 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 | 2020-01-03 |