MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for COR-KNOT MINI 031350 manufactured by Lsi Solutions, Inc..
[134332035]
Doctor was using cor knot device during the replacement of an aortic valve, the device misfired causing a cor knot needle to enter the aorta, causing an injury to the aorta. Device was removed from service. The inspiris aortic valve which had just been put in was removed, the hole was fixed and a new replacement inspiris aortic valve was put in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8284465 |
| MDR Report Key | 8284465 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-09 |
| Date of Event | 2019-01-07 |
| Report Date | 2019-01-09 |
| Date Reported to FDA | 2019-01-09 |
| Date Reported to Mfgr | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT MINI |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2019-01-29 |
| Model Number | 031350 |
| Lot Number | 736328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Manufacturer Address | 7796 VICTOR-MENDON RD. VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |