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 2020-02-10 for VENA SEAL CLOSURE SYSTEM SP-101 manufactured by Medtronic Ireland.
[178320976]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178320977]
Physician used venaseal occluding device to treat the patient's entire great saphenous vein (gsv). Ifu was followed. A guide wire was used for the insertion of the catheter. It was reported that at patient follow up approximately 7 weeks post procedure, a granuloma was observed. The granuloma has been removed in a new procedure with venaseal. There was no further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188591282]
Additional information: during index procedure, local anesthesia was used and compression was performed with the transducer. The catheter tip was located 5cm caudal to the saphenofemoral junction (sfj) prior to initial delivery of adhesive. The venaseal procedure was completed without issue and the vein closed. The granuloma was removed through a small incision in a separate procedure. No additional venaseal treatment was performed as was originally reported. The patient is doing well. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188592460]
Additional information: the pathology report confirms the presence of non-malignant fibrinoid material in the excised granuloma. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188592722]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00633 |
| MDR Report Key | 9686205 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-05-22 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Catalog Number | SP-101 |
| Lot Number | 55792 |
| 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 | 2020-02-10 |