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

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id#(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 using ultima activator ii reusable drive mech, they noticed the damage of the ultima activator.As the retractor handle broke and dislocated from its original position during the time of procudure and no patient harm reported.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure using ultima activator ii reusable drive mech, they noticed the damage of the ultima activator.As the retractor handle broke and dislocated from its original position during the time of procudure and no patient harm reported.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4, g7, h2, h6, h10 trackwise # (b)(6).A lot history record review was completed for the reported product lot number.There was no nonconformance, which could be considered related to the reported event recorded in the lot history.

Manufacturer Narrative

Trackwise # (b)(4).Testing of actual/suspected device: (10/213/67) the device was returned to the factory for evaluation on 06/30/2021.An investigation was conducted on 07/14/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The device was observed to be intact, no visual defects were observed.A mechanical evaluation was conducted.The device was able to move freely along the retractor with no physical or visual difficulties.The handle of the device was observed to be intact, no visual or physical defects were observed.Based on the returned condition of the device, the reported failure "break" was not confirmed.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9888294
• MDR Text Key: 185285197
• Report Number: 2242352-2020-00316
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: UA-5001
• Device Lot Number: 25148706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 56