MAUDE Adverse Event Report: MC3, INC. SOFT-FLOW AORTIC CANNULA

Catalog Number 5768

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  Injury  

Event Description

Triple-vessel disease, having cabg x 2.Cardiothoracic surgeon inserted aortic cannula.Noticed there was an issue with the cannula-connector bond.Due to this issue, surgeon placed a new aortic cannula.At the end of the procedure, the surgeon removed the aortic cannula.Replacing the initial aortic cannula caused the insertion hole to be larger and surgeon was unable to repair with initial safety sutures.Had to use add'l suture with pledgets placed to stop aortic bleeding.

• Brand Name: SOFT-FLOW AORTIC CANNULA
• Type of Device: SOFT-FLOW AORTIC CANNULA
• Manufacturer (Section D): MC3, INC.; minneapolis MN 55432
• MDR Report Key: 6900101
• MDR Text Key: 87742315
• Report Number: MW5072512
• Device Sequence Number: 0
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 5768
• Device Lot Number: 1607101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 96