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

Model Number C-UA-5001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for eval.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima drive handle on activator were stuck and blades did not retract.The hospital did not report any pt effects.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: CLAMP-LESS BEATING HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; wayne NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond dr. ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4996005
• MDR Text Key: 22966722
• Report Number: 2242352-2015-00646
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/09/2015

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: C-UA-5001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• 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