MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC RETROGRADE CORONARY SINUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Medtronic received information that while placing an edwards retrograde coronary sinus cannula, for surgical avr, there was noted to be some staining in the pericardiai space.The patient was found to have a perforation on the anterior surface of the rv which was not actively bleeding, but the patient had a blood clot in the pericardium.The surgeon also noted that the sternum "bled profusely" and it took about 15 minutes to get the bleeding under control.The patient had a total of two platelet infusions, two plasma units, and three units of packed cells during and after surgery to address the blood loss.Information regarding how the perforation was addressed were not provided.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RETROGRADE CORONARY SINUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17520927
• MDR Text Key: 321043055
• Report Number: MW5127875
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1