MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-26 for SYMMETRY ACN-4550 * manufactured by St Jude Medical, Inc..
[276400]
As physician attempted to use product during surgery the plastic sheath that attaches to the handle of the aortic connector dropped off making product unuseable. Device removed from the field and second device used successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025442 |
| MDR Report Key | 402560 |
| Date Received | 2002-06-26 |
| Date of Report | 2002-06-12 |
| Date of Event | 2002-05-08 |
| Date Added to Maude | 2002-07-03 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY |
| Generic Name | BYPASS SYSTEM AORTIC CONNECTOR |
| Product Code | DSS |
| Date Received | 2002-06-26 |
| Model Number | ACN-4550 |
| Catalog Number | * |
| Lot Number | 87628 |
| ID Number | * |
| Device Expiration Date | 2004-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391568 |
| Manufacturer | ST JUDE MEDICAL, INC. |
| Manufacturer Address | ONE LILLEHEI PLAZA ST PAUL MN 55117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-26 |