FDA Adverse Event
Malfunction
Summary report: N
AORTIC CUTTER 3.8 MM
MDR report key: 1632190
·
Received March 3, 2010
Report
- Report Number
- 2648729-2010-00526
- Event Type
- Malfunction
- Date Received
- March 3, 2010
- Date of Event
- January 20, 2010
- Report Date
- February 2, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- FZT
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AORTIC CUTTER DID NOT FIRE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC CUTTER 3.8 MM | AORTIC CUTTER | FZT | MAQUET CARDIOVASCULAR, LLC | AC-3038 | 9060572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |