FDA Adverse Event
Malfunction
Summary report: N
ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
MDR report key: 3050362
·
Received April 8, 2013
Report
- Report Number
- 2242352-2013-00312
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 19, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- MWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ULTIMA ACTIVATOR II REUSABLE DRIVE MECHANISM BROKE IN HALF WHILE CRANKING THE PT'S CHEST OPEN. NOTHING FELL INTO THE PT AND NO INTERVENTION WAS REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142464 | ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. | CLAMPLESS BEATING HEART | MWS | MAQUET CARDIOVASCULAR, LLC | UA-5001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |