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

Catalog Number C-UA-5001

Device Problem Difficult to Remove (1528)

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

Event Date 03/30/2017

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 preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mechanical deep blade will not come undone from activator drive.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The manufacturing date could not be populated as the material was not received in the wayne facility.This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.Specs of blood were observed on the blades.The right blade was returned attached to the ultima drive.The platform release latch on the right blade was broken off.There were no non-conformities observed on the left blade.The release latch was removed with tweezers and the ultima drive was separated from the right blade.There were no non-conformities with the drive.No other visual defects were observed.Based on the returned condition the reported failure ¿mechanical issue¿ was not confirmed.The certificate of conformance (c of c) was reviewed.The vendors certify that all the device lots manufactured conforms to all the applicable product specifications.There were no non-conformities observed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mechanical deep blade will not come undone from activator drive.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
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6519026
• MDR Text Key: 73828114
• Report Number: 2242352-2017-00412
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1