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	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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.Device discarded.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutter (3.8mm).They tried to make a hole in aorta.Unlocked it and pressed the button strongly, but the cutter did not come out firmly.Judging that it was a malfunction.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutter (3.8mm).They tried to make a hole in aorta.Unlocked it and pressed the button strongly, but the cutter did not come out firmly.Judging that it was a malfunction.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).The lot # 25152444 history record review was completed.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 batch manufacturing process and the reported failure.

• 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
• MDR Report Key: 11636156
• Report Number: 2242352-2021-00264
• Device Sequence Number: 17018333
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 07/07/2021
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: C-AC-3038
• Device Lot Number: 25152444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/06/2021
• Patient Sequence Number: 1