MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for COR-KNOT 031082 manufactured by Lsi Solutions, Inc..
[123349731]
During routine replacement of mitrl valve, the physician placed the cor-knot device around the suture and followed the stature down to the valve. The device misfired, cutting the suture distally instead of proximally, causing the cor-knot to fall into the right ventricle. The mitral valve 7300tfx29mm was removed, causing significant damaged to the valve. A second mitral valve was opened and successfully sutured in using cor-knot 031082, lot #708724.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080415 |
| MDR Report Key | 7946957 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-08-21 |
| Date Added to Maude | 2018-10-09 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COR-KNOT |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC POLYESTER |
| Product Code | GAS |
| Date Received | 2018-10-05 |
| Returned To Mfg | 2018-08-22 |
| Catalog Number | 031082 |
| Lot Number | 708724 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-05 |