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

Catalog Number C-UA-5001

Device Problems Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Was stuck and failed to open.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # tw (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.Only the drive mechanism was returned to the factory.The access rail platforms were not returned.The drive handle was detached from the drive mechanism.It was also observed that the pinion gear was detached from the drive handle.One of the pins on the detached pinion gear appeared slightly bent and twisted.A mechanical evaluation cannot be performed due to the returned condition of the device.Based on the evaluation results, the reported failure mechanical issue was not confirmed.The analyzed failure break was confirmed.This is a reusable oem device; therefore, a lot history review is not applicable.Based on the serial number provided, we were unable to find when the device was sold to the account.The certificate of conformance (c of c) was not available for review because, the reported serial number does not appear to be included in any of the batches received in maquet wayne.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Was stuck and failed to open.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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
• MDR Report Key: 8215356
• MDR Text Key: 132081175
• Report Number: 2242352-2019-00002
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: 12/19/2018
• Device Age: YR
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 119