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 2019-12-20 for FLOW COUPLER 519600001061 manufactured by Baxter Healthcare Corporation.
[172430780]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[172430781]
It was reported a patient underwent a bilateral diep (deep inferior epigastric perforators) procedure, in which coupler devices were used. It was reported that on the first breast, during eversion of vessel, the ring was pushed out of the wing jaw assembly. The coupler system was abandoned, and the vessel was anatomized with suture. On the second breast, a 2. 0mm coupler was used with approximated 2. 5mm internal mammary artery and 2. 0mm flap vessel, both were everted and closed with the coupler system. No thrombi were observed, however, the surgeon reported a whitening of tissue and darkening of veins. It was reported a side branch was opened and no blood flow was observed. The coupler devices were removed, and the vessels were re-anatomized with suture. The patient outcome was reported as? Fine?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-07082 |
| MDR Report Key | 9506240 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-20 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2019-12-20 |
| 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 | 2019-12-20 |
| 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 | 2019-12-20 |