MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-24 for COR-KNOT 030884 manufactured by Lsi Solutions.
[4126305]
Ldi solutions cor-knot device would not release after activating. Second device from package utilized for remainder of securements. Diagnosis or reason for use: minimally invasive aortic valve replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033614 |
| MDR Report Key | 3542256 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-23 |
| Date of Event | 2013-12-23 |
| Date Added to Maude | 2013-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT |
| Generic Name | COR-KNOT |
| Product Code | GAS |
| Date Received | 2013-12-24 |
| Model Number | 030884 |
| Catalog Number | 030884 |
| Lot Number | 16631 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-24 |