MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-18 for MECHANICAL VALVE SIZERS manufactured by St. Jude Medical, Inc..
[80282838]
Patient Sequence No: 1, Text Type: N, H10
[80282839]
One of the st jude plastic heart valve sizer broke into pieces while dr. Was using it to size mitral valve. Dr. Was able to gather all little pieces. Additional info: the last time this tray was modified in the system was 4 years ago, but pieces could have been replaced since then without record of that. Last year the tray was processed approximately 20 times at a rate of 6:45 at 270 degrees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6720962 |
| MDR Report Key | 6720962 |
| Date Received | 2017-07-18 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-06-26 |
| Report Date | 2017-06-27 |
| Date Reported to FDA | 2017-06-27 |
| Date Reported to Mfgr | 2017-06-27 |
| Date Added to Maude | 2017-07-18 |
| 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 |
| 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 | MECHANICAL VALVE SIZERS |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2017-07-18 |
| ID Number | MECHSZAO |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-18 |