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 2020-01-21 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[182397926]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182397927]
The physician used a vena seal closure system on the great saphenous vein (gsv). The ifu was followed during preparation, procedure and post-procedure. A guidewire was used for the insertion of the catheter. The entire vein was treated, and the vein was closed. It was reported that the patient had itching all over body one month after the procedure. The patient had been prescribed a medrol dose pack and famotidine/montelukast to treat the itchiness. The itching has been reported to be resolved.
Patient Sequence No: 1, Text Type: D, B5
[188432217]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188432527]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00341 |
| MDR Report Key | 9609593 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| 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 | 2020-01-21 |