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

Model Number	AORTIC CUTTERS, 5-PACK (3.8MM)
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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), an abnormality was found in the needle.The needle bent almost at a right angle, causing an abnormality.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 cutters, 5-pack (3.8mm), an abnormality was found in the needle.The needle bent almost at a right angle, causing an abnormality.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).The cutter device was returned to the factory for evaluation on 25aug2020 and investigated on 03sep2020.Signs of clinical use and evidence of blood were observed.Signs of blood observed on the body of the cutter.A visual inspection was conducted.The safety lock was disengaged and the actuation button fully depressed inside the tool with the cutter and spiral needle deployed.The needle appeared to be bent.The cutter was in a deployed state with the actuation button approximately 1 inch inside the tool.No other visual deformities were observed.Based upon the received condition of the device, the reported failure mode ¿material twisted/bent; needle¿ was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• Brand Name: AORTIC CUTTERS, 5-PACK (3.8MM)
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10451575
• Report Number: 2242352-2020-00729
• Device Sequence Number: 16973314
• Product Code: DXC
• 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,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 02/05/2021
• Device Model Number: AORTIC CUTTERS, 5-PACK (3.8MM)
• Device Catalogue Number: AC-3038
• Device Lot Number: 25150078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1