MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; CLAMP-LESS BEATING HEART

Model Number UA-5001

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, the drive on the ultima activator ii reusable drive mech.Is "starting to stick and is a little hard to crank".The device was not being used on a patient and the hospital did not report any patient effects.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Since this is an oem supplied device, a lot history review is not applicable.(b)(4).

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
• Type of Device: CLAMP-LESS BEATING HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 4222734
• MDR Text Key: 5064486
• Report Number: 2242352-2014-00841
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UA-5001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1