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 Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech have rust formation.No patient involvement.Related to (b)(4) (complaint 2 of 3).

Event Description

Summary: the hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech have rust formation.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4) the dhr shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The device was returned to the factory on 07/31/2020.Photographs were provided by the account.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion on the device itself.The trade name maquet engraved on the device as well as on the us patent engraving appeared to be brown resembling rust of corrosion.No other visual defects were observed.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion on the device itself.The trade name maquet engraved on the device as well as on the us patent engraving appeared to be brown resembling rust of corrosion.Based on the returned condition of the device, the reported failure "corrosion" was 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: 10303066
• MDR Text Key: 199864274
• Report Number: 2242352-2020-00631
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: D033986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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
• Device Lot Number: 25146474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1