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

Catalog Number C-UA-5001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech was placed on the patient's chest and one of the blades came off.The surgeon tried to put the blade back on the activator drive but as soon as it was placed on the chest the blade kept coming off.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).Internal complaint number: (b)(4).Auto number: (b)(4).(b)(4).A serial/lot number was not provided and the specific product serial/lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech was placed on the patient's chest and one of the blades came off.The surgeon tried to put the blade back on the activator drive but as soon as it was placed on the chest the blade kept coming off.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
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6672484
• MDR Text Key: 78585375
• Report Number: 2242352-2017-00622
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• 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