MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-UA-5001

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech retractor malfunctioned during a case and it locked up.The hospital did not report any patient effects.A replacement device was not used to complete the procedure.It was very difficult to crank open.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical usage with no evidence of blood were observed.No visual defects were observed.A mechanical evaluation was conducted.The drive handle was cranked in both counterclockwise and clockwise directions.It was observed that there was no difficulty cranking or retracting the drive handle.The drive handle was removed from the activator drive mechanism.It was observed that there was no difficulty in removing the drive handle.Based on the condition of the device and the results of the investigation, the reported complaint was not confirmed for the failure mode "mechanical issue.".

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech retractor malfunctioned during a case and it locked up.The hospital did not report any patient effects.A replacement device was not used to complete the procedure.It was very difficult to crank open.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6564746
• MDR Text Key: 75309311
• Report Number: 2242352-2017-00484
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: PA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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 Catalogue Number: C-UA-5001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1