MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AORTIC CUTTERS, 5-PACK (4.3MM); LOCATOR, MAGNETIC

Model Number	AORTIC CUTTERS, 5-PACK (4.3MM)
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2022
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 the aortic cutters, 5-pack (4.3mm) unlock button was harder than usual.They didn't use it just in case, but they opened a new product of the same size and could use it without any problem.There is no damage to the patient's health.
Event or Problem Description
N/a.
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/serial 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/serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period apr 2020 through mar 2022 was reviewed.There were no triggers identified for the review period.

• Brand Name: AORTIC CUTTERS, 5-PACK (4.3MM)
• Common Device Name: LOCATOR, MAGNETIC
• 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: 14051122
• Report Number: 2242352-2022-00305
• Device Sequence Number: 5876860
• Product Code: FTZ
• UDI-Device Identifier: 00607567700277
• UDI-Public: 00607567700277
• 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): 05/13/2022

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: 03/16/2022
• Device Model Number: AORTIC CUTTERS, 5-PACK (4.3MM)
• Device Catalogue Number: C-AC-3043
• Device Lot Number: 25157119
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown