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 2020-02-28 for VESSEL EVERTER SYSTEM 519600001061 manufactured by Baxter Healthcare Corporation.
[184176885]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184176886]
It was reported a patient underwent a bilateral diep (deep inferior epigastric perforator) procedure, in which a vessel everter device and 2. 0 coupler were used. It was reported the arteries involved internal mammary artery (ima) and deep inferior epigastric arteries (diea) measured 2. 0mm (left and right sides). The surgeon reported the angle of the everter made it difficult to see the area of interest and noted a pressure gauge would prevent application of excess pressure. It was reported this caused damage and tears the arteries. Tears were visible on both flaps, however, the right flap required removal of flow coupler and re-anastomosis with suture. The surgeon reported the area over the coupler pins was? Too heavily worked and handled, risking an arterial tear?. It was reported? No resulting harm was experienced by the patient?. The patient outcome was reported as? Coupler was removed on one side and successful anastomosis achieved with suture?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01085 |
| MDR Report Key | 9771908 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-02-28 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VESSEL EVERTER SYSTEM |
| Generic Name | DEVICE, ANASTOMOTIC, MICROVASCULAR |
| Product Code | MVR |
| Date Received | 2020-02-28 |
| Model Number | NA |
| Catalog Number | 519600001061 |
| Lot Number | SP19F25-1381499 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |