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

Model Number RC2012

Device Problems Material Rupture (1546); Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The retrograde cannula is used intermittently to deliver retrograde cardioplegia administration during cardiac surgery.If a leak is not noticed during the routine flushing of the device during preparation; exchange to an unaffected device could easily be done during the case since cardioplegia is delivered intermittently and the catheter is easily accessible due to the accessibility of the device and the cardiac structures.In addition, 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, a piece of the balloon was reported as missing and the coronary sinus had a tear that was repaired.The root cause of this event cannot be conclusively determined with the available information.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.

Event Description

It was learned that upon removal of the coronary sinus catheter, it was noted that a small piece of the occlusion balloon was missing.The coronary sinus also had a tear in it and was repaired.The patient at the time of reporting was doing well.No patient complications reported.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Manufacturer Narrative

Additional information was received and the following section(s) was updated.

Event Description

It was reported that upon removal of the rc2012 cannula, it was noted that there was a hole in the balloon with a small piece of the occlusion balloon missing.It is unknown if the missing piece is in the patient or not.Additionally, the coronary sinus also had a tear in it, and was repaired.The patient at the time of reporting was doing well.No patient complications reported.

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: 7964790
• MDR Text Key: 123685589
• Report Number: 3008500478-2018-00088
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Device Lot Number: 61339985
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 11/19/2018; 07/23/2020
• Supplement Dates FDA Received: 11/20/2018; 12/06/2018; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention