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 2020-02-13 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[179436686]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179436687]
During procedure, venaseal occluding device was used to treat 7 segments in the great saphenous vein (gsv) in one leg without incident. Patient then received venaseal again and about 4 - 6 weeks after treatment, complained of redness by the access site. Patient was instructed to take medtrol dose pack and contact clinic if symptoms persist. It was discovered that the patient did not take the dose pack nor contacted the office. Patient presented to dermatologist and was placed on antibiotics. The patient has taken the antibiotics prescribed by the dermatologist. Patient is now about 18 months out of treatment date and complaining of slight ulceration and possible e. Coli infection. No further patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[182473198]
Additional information: both left and right legs were treated on the same date. The patient first presented with symptoms 4-6 weeks post procedure. The patient is scheduled for a follow-up visit. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182473589]
Additional information: the patient is reported to be doing much better. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188633517]
Additional information: the physician reported presence of adhesive at the access site resulting in a 2 cm dark lesion, on one of the 2 legs treated. No issues with the other leg. Patient was not seen in the practice for 18 months, so physician assumed the patient was doing fine. She returned to the facility presenting some minor issues at the access site. Patient was seen by a plastic surgeon to see about removing/exploring the site. This has been performed and patient was left with a small scar. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00712 |
| MDR Report Key | 9706326 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-24 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Catalog Number | VS-402 |
| Lot Number | 50547 |
| Device Expiration Date | 2020-02-28 |
| 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 | 2020-02-13 |