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

Model Number	AORTIC CUTTERS, 5-PACK (4.3MM)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Event or Problem Description
In the course of an online primary market research the respondent stated the following: in performing off-pump cabg procedures (opcab), the following heartstring iii with aortic cutter 4.3mm (getinge) was personally used in the past 12 months.Rate level of agreement with the following statement as it relates to heartstring iii with aortic cutter 4.3mm (getinge).The heartstring iii seal provides adequate hemostasis needed to complete the proximal anastomosis.Comments: the hemostatic effect is unsatisfactory.
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
In the course of an online primary market research the respondent stated the following: in performing off-pump cabg procedures (opcab), the following heartstring iii with aortic cutter 4.3mm hemostatic effect is unsatisfactory.
Additional Manufacturer Narrative
(b)(4).Updated section: b4, g4, g7, h2, h6, h10, h11 corrected section: b1, b5, h1 a lot history review was not completed as there was no account reported or event date reported as this was part of a market research by a third party.

• Brand Name: AORTIC CUTTERS, 5-PACK (4.3MM)
• Common Device Name: CUTTER, SURGICAL
• 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: 15414325
• Report Number: 2242352-2022-00781
• Device Sequence Number: 17552872
• Product Code: FZT
• UDI-Device Identifier: 00607567700277
• UDI-Public: 00607567700277
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AORTIC CUTTERS, 5-PACK (4.3MM)
• Device Catalogue Number: AC-3043
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown