MAUDE Adverse Event Report: MC3, INC. SOFTFLOW AORTIC CANNULA

Model Number 7071

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/02/2017

Event Type  Injury  

Event Description

Reporting 3rd incident involving medtronic softflow aortic cannula used during open heart surgery.We have had 2 major incidents involving the 8.0 mm (24f) model 5768 softflow aortic cannula, the last one (according to perfusionist.) "had we gone on bypass with the cannula, had the great potential of death for the pt." our perfusionist also stated "there is obviously a mfg defect with this cannula.The connector is improperly bonded to the main body of the cannula.I thought this was only the problem with the 8.0 mm cannula.Yesterday, at the end of the case (the case i'm reporting now), another staff member in the cvor noticed a 6.0 (18f; model number 7071) cannula had the same thing happen to it.Unfortunately, the cannula was not preserved.I just found out about it this morning.".

• Brand Name: SOFTFLOW AORTIC CANNULA
• Type of Device: SOFTFLOW AORTIC CANNULA
• Manufacturer (Section D): MC3, INC.; minneapolis MN 55432
• MDR Report Key: 6916128
• MDR Text Key: 88449052
• Report Number: MW5072619
• 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: 10/03/2017

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 Model Number: 7071
• Device Catalogue Number: 7071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2017
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 108