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

Model Number RC2014

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The retrograde cannula is used intermittently to deliver cardioplegia solution during cardiac surgery.Rupture of the balloon during use can result in injury to the patient.The subject device has been requested to be returned for evaluation.If returned and evaluated, a supplemental report will be submitted.The device history record (dhr) was not reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that the balloon of a rc2014 retro cannula ruptured during use.The flow rate of cardioplegic solution was from 260 to 270 ml/ min.The coronary sinus pressure was approximately 30 mmhg, and there was no problem confirmed.However, after hearing the explosive sound, the coronary sinus pressure was lost, and an approximately 3cm long and 3 cm wide size of hiatus detected in the right atrium.The device was returned for evaluation.There was no missing balloon remained in the patient body.The surgeon commented that this event was device related.File will be updated.

Manufacturer Narrative

H3: evaluation summary: customer complaint that "the balloon ruptured" was confirmed.Balloon failed inflation test due to a balloon rupture.As received, edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.Device was returned with visible traces of blood and was examined in the biohazard area of lab.No other visual damage, contamination, or other abnormalities were found to the device.

Event Description

It was reported that the balloon of a rc2014 retro cannula ruptured when the customer was injecting the terminal warm blood cardioplegia.The cannula was used for aortic valve replacement.The flow rate of cardioplegic solution was from 260 to 270 ml/ min.The coronary sinus pressure was approximately 30 mmhg.The customer was using the device as usual.However, during infusion of the terminal warm blood cardioplegia, a bursting sound was heard without any signs and the balloon ruptured.After hearing the bursting sound, the coronary sinus pressure was lost and the customer immediately stopped injecting cardioplegia solution.It was confirmed that the damage penetrating the right atrium at the coronary vein near the coronary sinus.Approximately 3cm long and 3cm wide size of tear was found at the right atrium.Cardioplegia solution was injected again antegradely and aorta was re-clamped to treat the damage.The patient status was reported as ¿recovering¿.The device was returned for evaluation.There was no missing balloon remained in the patient body.Pumping duration for aortic valve replacement surgery at this hospital is normally around 120 minutes, however, the total pumping duration of this surgery was 219 minutes.Duration time of using the device was unknown.The surgeon commented that this event was device related.

• Brand Name: RETROGRADE 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: 10443326
• MDR Text Key: 204174675
• Report Number: 3008500478-2020-00204
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: RC2014
• Device Catalogue Number: RC2014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention