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 2020-02-24 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[180635905]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[180635906]
Physician used a venaseal occluding device during procedure to treat the great saphenous vein (gsv). The lumen was flushed prior to use. Ifu was followed. A guide wire was used for the insertion of the catheter. It was reported that post procedure, patient reported access site issues with irritation, drainage and discoloration. Patient reportedly has a healed access site wound at this time. It was advised to debride the access site for a glue remnant if symptoms re-appear. Antibiotics were prescribed during the initial phase and post procedure. Patient is in follow-up phase with a healed access site wound, which had previously been irritated with drainage and discoloration. No further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[188748917]
Additional information: venaseal treatment was performed in one limb only. The catheter tip was located 5cm caudal to the great saphenous vein prior to initial delivery of adhesive. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188749184]
Additional information: the patient had a hypersensitivity reaction within 24 hours of her initial treatment. About three and half months later, the patient went to the hospital after experiencing a 102? F fever and not alerting the facility over the weekend. The physician noticed the patient has terrible cellulitis and needed an iv antibiotic. The patient was sent to a hospital and was prescribed rocephin and vanco. The patient is currently hospitalized. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188749252]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00852 |
| MDR Report Key | 9744779 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2020-02-24 |
| Catalog Number | VS-402 |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-24 |