MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; NONE

Model Number UA-5001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

The hospital reported that the retractor of the ultima activator ii reusable drive mech.Did not move along the drive very smoothly and was difficult to turn.The same device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot number.(b)(4).

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: NONE
• 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: 4172450
• MDR Text Key: 5086668
• Report Number: 2242352-2014-01066
• 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: 09/11/2014

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
• Device Lot Number: 25102583
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 84