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 Patient Involvement (2645)

Event Date 09/22/2020

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 mech retractor broke following procedure, during pre-clean on its way to sterile supply.No patient involvement.

Manufacturer Narrative

Updated sections: g4, g7, h2, h3, h6, h10 trackwise # (b)(4).A ship history to the account for the year prior to the reported event date was performed.There were no recorded sales of this product to the reported account.A lot number was not provided by the hospital.The device was returned to the factory for evaluation on 10/09/2020.An investigation was conducted on 01/12/2021.A visual inspection was conducted.Signs of clinical use and slight evidence of discoloration was observed on the activator ii drive mechanism.In the middle of the drive mechanism it was observed to be cracked and separated.There were no other visual defects observed.Based on the returned condition of the device, the reported failure "break" was confirmed as well as for the analyzed failure "corrosion".The c of c was unavailable to be obtained as the serial number that was reported isn't connected to any products with the reported serial #.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech retractor broke following procedure, during pre-clean on its way to sterile supply.No patient involvement.

• 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: 10708785
• MDR Text Key: 212283349
• Report Number: 2242352-2020-00903
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• 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: 10/19/2020

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 Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: UA-5001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1