FDA Adverse Event
Malfunction
Summary report: N
AORTIC CUTTER 3.8 MM
MDR report key: 1648766
·
Received March 26, 2010
Report
- Report Number
- 2648729-2010-00848
- Event Type
- Malfunction
- Date Received
- March 26, 2010
- Date of Event
- February 19, 2010
- Report Date
- February 26, 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 IF ADDITIONAL INFORMATION IS OBTAINED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CUTTER DID NOT COME OUT OF THE AORTIC CUTTER. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. 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 | 9061071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |