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 2019-12-18 for FLOW COUPLER 519600001061 manufactured by Baxter Healthcare Corporation.
[171857731]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[171857732]
It was reported that a tearing occurred during anastomosis of two arteries ( ima and the deep inferior epigastric artery (diea)), while using a new coupler system and 2. 5mm coupler ring. It was reported that during the diep flap procedure, the first artery (ima) was coupled successfully whilst the second artery (diea) began tearing when everting. The surgeon had to use an alternative to the coupling system. The patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-06989 |
| MDR Report Key | 9490301 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-18 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2019-12-18 |
| 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 | FLOW COUPLER |
| Generic Name | DEVICE, ANASTOMOTIC, MICROVASCULAR |
| Product Code | MVR |
| Date Received | 2019-12-18 |
| 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 | 2019-12-18 |