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

Model Number RC014T

Device Problem Inflation Problem (1310)

Patient Problem Sinus Perforation (2277)

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported when the surgeon tried to remove the retrograde cardioplegia cannula, the coronary sinus ruptured due to a ¿faulty cannula¿.The rupture of the coronary sinus lead to unnecessary extension of the sternotomy wound, prolonged cardiopulmonary bypass (cpb), blood loss, and the administration of blood products.There was no difficulty encountered during device insertion and cardioplegia delivery was performed without issues.The device removal was performed after coming off cpb.The patient did not have unusual anatomy, but the surgeon did note this male patient in his mid-(b)(6) had ¿delicate tissues¿.The patient condition was noted as discharged.

Manufacturer Narrative

Device evaluation is currently underway.

Manufacturer Narrative

Results: material degradation/deterioration, unanticipated or unexpected.Additional manufacturer narrative: the device was returned to edwards for evaluation and the reported condition was confirmed.As received, a cannula balloon aneurysm was observed.The cannula balloon inflated without leakage, but an aneurysm formed from a possible weakened area in the wall of the balloon.The aneurysm protruded out of the cannula balloon approximately 1.5 cm.No other visual damages, contamination, or other abnormalities were found.No manufacturing non-conformities were found in the returned sample.Root causes and corrective actions for this failure will be addressed through the edwards quality system.Manufacturing records were unable to be reviewed as no lot number was provided.The fmea was found to adequately address potential causes of the failure and the associated hazards.A review of the ifu was conducted and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint trend was assessed and was found to be in control.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4824639
• MDR Text Key: 21183221
• Report Number: 3008500478-2015-00035
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RC014T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• 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
• Patient Weight: 50