MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AORTIC CUTTERS, 5-PACK (3.8MM); CUTTER, SURGICAL

Model Number	AORTIC CUTTERS, 5-PACK (3.8MM)
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutters (3.8mm).They pressed the cutter operation button after releasing the safety lock, but the button was hard and the cutter did not come out.There was no problem when they prepared and used a substitute cutter.
Additional Manufacturer Narrative
Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutters (3.8mm).They pressed the cutter operation button after releasing the safety lock, but the button was hard and the cutter did not come out.There was no problem when they prepared and used a substitute cutter.It has no effect on the patient.

• Brand Name: AORTIC CUTTERS, 5-PACK (3.8MM)
• Common Device Name: CUTTER, SURGICAL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12526141
• Report Number: 2242352-2021-00761
• Device Sequence Number: 1547841
• Product Code: FZT
• UDI-Device Identifier: 00607567700260
• UDI-Public: 00607567700260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: AC-3038
• Device Lot Number: 25157565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown