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 2020-02-05 for VESSEL EVERTER SYSTEM 519600001061 manufactured by Baxter Healthcare Corporation.
[177851734]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177851735]
It was reported a patient underwent a bilateral diep (deep inferior epigastric perforator) procedure, in which coupler and a vessel everter device were used. It was reported the first vessel (2. 5mm diea) engaged successfully on all coupler rings. The second vessel (internal mammary artery, ima approx. 3. 0mm), 2 pins were initially engaged on the ring,? Which popped out?. It was reported the surgeon used a curved dilator to secure the vessel on the ring pins, during which the intimal lining began to tear. It was reported the surgeon cut out the coupler, trimmed and sutured the arteries to achieve successful anastomosis. The surgeon reported the ima tissue was? Suspect?. It was reported there were no patient symptoms or impact to the patient. The patient outcome was reported as? A successful anastomosis was achieved by suturing the vessels?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00422 |
| MDR Report Key | 9671994 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| 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 | 2020-02-05 |