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 2020-01-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[182395241]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182395242]
Patient had short saphenous vein treated with venaseal. Procedure completed successfully and the vein is reported to have closed. It is reported the patient developed a foreign body reaction described as a? Venaseal cap? Comprising of a white pimple with redness around the area approximately 5 months post procedure in the right small saphenous vein. The physician performed a debridement procedure to remove and found it to be grainy/granular venaseal material. The patient was administered antibiotics (augmentin, levaquin and bacitracin). The wound is reported to be slowly healing.
Patient Sequence No: 1, Text Type: D, B5
[188281589]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188281597]
Additional information update: patient had right short saphenous vein treated with venaseal for 20 centimeters with 1. 0 cc adhesive administered. There was no difficulties noted to the location of the catheter tip prior to the initial delivery of adhesive. The catheter tip was 5 cm caudal to the sfj. The patient is still recovering and well. The wound is expected to be healed in 2 weeks. Index procedure date and symptoms onset date were provided. Event occurred 2 months post procedure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00023 |
| MDR Report Key | 9537714 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| 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. Required No Informationntervention | 2020-01-02 |