MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-24 for COR-KNOT * 030800 manufactured by Lsi Solutions, Inc.
[16183340]
Cor-knot device did not deploy properly, causing the wire to break while attaching the mitral valve implant, thus requiring manual removal of the wire, suture & pledget from the implant placement area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4091412 |
| MDR Report Key | 4091412 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-05-07 |
| Report Date | 2014-07-24 |
| Date Reported to FDA | 2014-07-24 |
| Date Reported to Mfgr | 2014-09-16 |
| Date Added to Maude | 2014-09-16 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT |
| Generic Name | SUTURE |
| Product Code | GAS |
| Date Received | 2014-07-24 |
| Model Number | * |
| Catalog Number | 030800 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2014-07-24 |