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	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, aortic cutters (3.8mm) was not sharp.The new punch was used again and the operation was finished.The hospital did not report any patient effects.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, aortic cutters (3.8mm) was not sharp.The new punch was used again and the operation was finished.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Updated sections: g4,g7,h2,h3,h6,h10.Internal complaint number: 368349.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 for evaluation on 10/01/2020.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood was observed on the aortic cutter.The safety lock was disengaged with the cutter and spiral needle deployed.The cutter was in a deployed state with the actuation button approximately 1 inch inside the tool.The tip of the needle was observed to be slightly bent.No other visual defects were observed.Based upon the received condition of the device, the reported failure mode ¿failure to cut¿ was not confirmed but was confirmed for the analyzed failure "material twisted/bent needle".
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, aortic cutters (3.8mm) was not sharp.The new punch was used again and the operation was finished.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).The lot # 25148394 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 07470
• MDR Report Key: 10667211
• Report Number: 2242352-2020-00877
• Device Sequence Number: 14443091
• 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,Followup
• Report Date (Section B): 10/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: AC-3038
• Device Lot Number: 25148394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 10/29/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/23/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1