MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SELF-INFLATING RETROGRADE CARDIOPLEGIA CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number RC2012

Device Problem Inflation Problem (1310)

Patient Problem Perforation of Vessels (2135)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation, as it was discarded by the customer.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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 reported that the patient coronary sinus got ruptured at third balloon inflation of rc2012 retro cannula.The coronary sinus pressure was 30 mmhg and pressure within the circuit was 190mmhg.The flow rate of cardioplegic solution was from 300 ml/ min.The tip position was appropriate.Inflation test before use was with saline was not performed.The cannula was not occluded.After the coronary artery rupture, the device was removed immediately from the patient and selective cannulation was performed in replacement.The patient status was reported as recovered.The device will not be returned for evaluation as it was discarded by the hospital.The customer commented that the balloon size seemed to be bigger than 18mm, which was indicated in the catalog.It got hardened too.The balloon was intact.The ruptured site was repaired.There were no abnormalities noted on the cannula before use.The balloon was inflated with the solution of 1:1 ratio for mixture (lactec, potassium, acda solution and peresivin) and blood.

Manufacturer Narrative

Complaint unable to be confirmed.There is no evidence to suggest an edwards manufacturing defect.Root cause analysis: per event description, it was reported that the patient coronary sinus got ruptured at third balloon inflation of rc2012 retro cannula.The coronary sinus pressure was 30 mmhg and pressure within the circuit was 190mmhg.The flow rate of cardioplegic solution was from 300 ml/min.A dhr review was unable to be performed as no lot number was provided.Based on the information available, the most likely cause of the reported event was a flow rate of 300ml/min.Per the ifu warnings and precautions, flows in excess of 120 ml/min may result in balloon overinflation and/or coronary sinus injury.An edwards defect has not been confirmed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: SELF-INFLATING RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17195745
• MDR Text Key: 317805804
• Report Number: 2015691-2023-14159
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization