MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for FLO-THRU FT12125 manufactured by Baxter Healthcare Corporation.
[184051710]
The device was received for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection with the unaided eye noted the foreign material appeared rigid and pin-like, not flexible. Upon viewing under a microscope, lengthwise edges appear rounded and the material fit inside the lumen of the returned flo-thru device. The dimensional measurements of the foreign object and the pin were similar enough to conclude the foreign object was part of the fixture. The foreign object inside the lumen was verified. The cause of the event was determined to be a pin. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184051711]
It was reported that there was lack of blood flow on the opposite end of the shunt of a flo-thru device when a physician inserted the distal bulb of the shunt into the coronary artery and tried to confirm blood flow by removing the air. This event was observed before the anastomosis was completed. It was reported that while attempting to flush the shunt to assess flow, a piece of wire-like object (approximately 7mm in length) was discovered from the shunt. The shunt was eventually flushed out with saline before placing in the vessel. The physician stated they would? Try to place pressure? Into the shunt by using a syringe before use, after this issue. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01508 |
| MDR Report Key | 9850504 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-18 |
| 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 | FLO-THRU |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-27 |
| Model Number | NA |
| Catalog Number | FT12125 |
| Lot Number | SP19C041357737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |