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 Codes	Mechanical Problem (1384); Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).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 or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutters, 5-pack (3.8mm), they felt that the cap part was loose from the beginning and was not firmly attached.When pressing the button to unlock and pull out the cutter, it was necessary to press harder than usual.The procedure was completed with the same device.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 25150913 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.The device was returned to the factory for evaluation on 02/03/2021.An investigation was conducted on 02/17/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the cap.A mechanical evaluation was conducted.The cap was returned off the device and put back on with no physical or visual difficulties.The cap fit was snug and was able to be removed with no physical or visual difficulties.The blade was in a deployed state and we were unable to determine the amount of force for the deployment of the needle.Measurements were taken of the cutter; from the tip of the needle to the grey part is.599, from the button that is pressed in is.403" inside the cutter, which is within normal limits.Based on the returned condition of the device, both reported failures "mechanical issue" and "poor quality issue¿ were not confirmed.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using aortic cutters, 5-pack (3.8mm), they felt that the cap part was loose from the beginning and was not firmly attached.When pressing the button to unlock and pull out the cutter, it was necessary to press harder than usual.The procedure was completed with the same device.The hospital did not report any patient effects.

• 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 07470
• MDR Report Key: 11279015
• Report Number: 2242352-2021-00103
• Device Sequence Number: 16816380
• 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): 02/04/2021

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: 03/20/2021
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: C-AC-3038
• Device Lot Number: 25150913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1