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 2020-02-03 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.
[186186049]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186186050]
During procedure, physician used venaseal occluding device to treat a segment in the great saphenous vein (gsv). Six days later, patient was admitted and treated with antibiotics and medrol dose pac, patient also on keflex. Physician noted that if no improvement, patient might need incision and drainage of distal thigh.
Patient Sequence No: 1, Text Type: D, B5
[188585984]
Additional information: there were no challenges or deviations related 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 reported to be doing better and the affected area is draining clear. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586443]
Image review: two photos of the patients leg was received for analysis. The photos show redness at the suspected insertion location. The observed redness shows characteristics of a potential infection. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586561]
Additional information: the physician provided a referral to an infection disease specialist. There is no update on whether the patient has gone to the specialist yet or not. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188586649]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00526 |
| MDR Report Key | 9659751 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2018-11-26 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| Catalog Number | VS-402 |
| Lot Number | 53718 |
| 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 | 2020-02-03 |