MAUDE Adverse Event Report: MEDTRONIC, INC. DLP AORTIC ROOT CANNULA WITH FLOW-GUARD INTRODUCER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 21014

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

Patient Problem Aortic Dissection (2491)

Event Date 09/11/2018

Event Type  Injury  

Event Description

The patient sustained an aortic dissection during placement of cannula for cardiopulmonary bypass.

Event Description

The patient sustained an aortic dissection during placement of cannula for cardiopulmonary bypass.The dissection was treated conservatively.No surgical intervention.

• Brand Name: DLP AORTIC ROOT CANNULA WITH FLOW-GUARD INTRODUCER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8539314
• MDR Text Key: 142733635
• Report Number: 8539314
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28835 DA
• Patient Weight: 93