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

Model Number RC2012

Device Problems Inflation Problem (1310); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Vascular perforations may occur with the use of several of our devices.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.In this case, it was reported that there was tearing of the coronary sinus (cs) during use with the rc2012.The balloon inflated eccentrically with a globular shape on the side of the balloon while inflating.The root cause cannot be conclusively determined with the available information.It is unknown whether patient and/or procedural related factors may have contributed to the event.The subject device has not been returned for evaluation.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

It was reported that during use of the retrograde device, bleeding was observed due a torn coronary sinus.As reported, the balloon inflated eccentrically.A globular shape was confirmed on a side of the balloon while inflating.The lateral diameter of the balloon got wider than normal.Another device was used.No additional information was provided.

Manufacturer Narrative

Customer report that "balloon inflated eccentrically" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, a cardioplegia balloon aneurysm was observed.The cardioplegia balloon inflated without leakage, but an aneurysm formed from a weakened wall of the balloon.All through lumens were patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Unfortunately, the root cause of this event cannot be determined at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: RETROGRADE CORONARY SINUS CARDIOPLEGIA CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8038481
• MDR Text Key: 126152770
• Report Number: 3008500478-2018-00089
• Device Sequence Number: 0
• Product Code: DWF
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention