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 2020-01-31 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[177120090]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177120091]
Physician used venaseal occluding device during procedure to treat the great saphenous vein (gsv). The ifu was followed during preparation, procedure and post procedure. No guide wire was used for the insertion of the catheter. The length of the vein and volume of adhesive used are unknown. The procedure was completed normally with no additional treatment required. The catheter tip 5cm was caudal to sfj. It was reported that the wound healing at the access site is not healing and there is polymerized venaseal extruding from the target vessel. A segment of the polymerized glue was surgically removed approximately 3. 5 months post procedure. The patient has been prescribed antibiotics. The patient is currently hospitalized, recovering from venaseal excision secondary to e. Coli infection.
Patient Sequence No: 1, Text Type: D, B5
[182473636]
Additional information: the patient has been discharged from the hospital and the infection has been fully resolved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188475459]
Image review: one image received for evaluation show a polymerized adhesive extruding from the target vessel. The report indicated the segment of the polymerized glue was surgically removed approximately 3. 5 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 | 9612164-2020-00492 |
| MDR Report Key | 9651926 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-05-13 |
| Date Added to Maude | 2020-01-31 |
| 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 | 2020-01-31 |
| Catalog Number | VS-402 |
| Lot Number | 55685 |
| 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 | 2020-01-31 |