MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC PRODUCT NOT IN LIST - BEATING HEART; CLAMP, VASCULAR

Model Number PRODUCT NOT IN LIST - BEATING HEART

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 Description

The hospital reported through the heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure, aortic cutter sometimes results in a.5mm "tear" on the aortotomy edge.They use a manual punch to make it more perfect.No patient harm has ever occurred because of this issue.The.5mm ¿tear¿ that is noted ¿rarely occurs¿ but he brought this up during the advisory board meeting to see if other surgeons are noting this issue during use of the hs iii device.He frequently uses more than one and often uses three different hs iii devices during one opcab procedure.He has never noted the ¿tear¿ to occur more than once on any case.He concludes that the ¿tear¿ may be due to how he removes the cutter from the aortotomy after ¿firing¿ the aortic cutter, or, it may be caused by the device tension spring tether.Occurrence of the ¿tear¿ does not seem to be related to aorta thickness, or a thin aorta.Nor has he noted this issue being related to the patient¿s age or quality of the aorta.He reiterated that this ¿rarely occurs, maybe 2-3 times per year at the most¿.No patient harm has ever occurred because of this issue.Nor has he ever had to alter his planned surgical procedure.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: event description corrected.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2020 through (b)(6) 2022 was reviewed.There were no triggers identified for the review period.

Event Description

Statement from the heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure, aortic cutter sometimes results in a.5mm "tear" on the aortotomy edge.They use a manual punch to make it more perfect.No patient harm has ever occurred because of this issue.The.5mm ¿tear¿ that is noted ¿rarely occurs¿ but he brought this up during the advisory board meeting to see if other surgeons are noting this issue during use of the hs iii device.He frequently uses more than one and often uses three different hs iii devices during one opcab procedure.He has never noted the ¿tear¿ to occur more than once on any case.He concludes that the ¿tear¿ may be due to how he removes the cutter from the aortotomy after ¿firing¿ the aortic cutter, or, it may be caused by the device tension spring tether.Occurrence of the ¿tear¿ does not seem to be related to aorta thickness, or a thin aorta.Nor has he noted this issue being related to the patient¿s age or quality of the aorta.He reiterated that this ¿rarely occurs, maybe 2-3 times per year at the most¿.No patient harm has ever occurred because of this issue.Nor has he ever had to alter his planned surgical procedure.

• Brand Name: PRODUCT NOT IN LIST - BEATING HEART
• Type of Device: CLAMP, VASCULAR
• 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: 13841331
• MDR Text Key: 287560480
• Report Number: 2242352-2022-00256
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - BEATING HEART
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention