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

Model Number RC2012

Device Problem Burst Container or Vessel (1074)

Patient Problem Perforation of Vessels (2135)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that the balloon of rc2012 retrograde cardioplegia cannula ruptured during use with a concomitant rupture of the patient's coronary sinus occurred.The cannula was inserted to the coronary sinus and the cardioplegia solution was injected.At first, the coronary sinus pressure was indicated as 20mmhg, however the pressure went down to a single digit level.The cannula was removed, and the balloon rupture was confirmed then.At the same time, the patient coronary sinus was also confirmed to be ruptured.The patient coronary sinus was repaired and another rc2012 retrograde cardioplegia cannula was used.The surgery was completed, and the patient status was reported as 'under treatment'.There was no calcification of coronary sinus.The flow rate of cardioplegic solution was 200 ml/min, but the injection pressure did not rise, so the flow rate was risen to 300ml/min.The cannula was inserted when the patient was partially on cardiopulmonary bypass.The location of the tip of the cannula was correct as the surgeon was placing his hand to the patient's heart and checking it by the echo.Balloon inflation test before use was probably not performed.Inconsistencies of the device were probably not noted before use.There was no kink on the cannula.The customer commented that the reason for the coronary sinus rupture whether it was device related or patient/procedural related was unknown.The device was stored flat at the hospital.

Manufacturer Narrative

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.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: h2 and h6 (type of investigation).Product evaluation: the customer complaint of balloon rupture 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.No other visual damage, contamination, or other abnormalities were found to the device.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.

Manufacturer Narrative

Root cause analysis: it was reported that the balloon of rc2012 retrograde cardioplegia cannula ruptured after the first dose of cardioplegia solution with a concomitant rupture of the patient's coronary sinus occurred.The cannula was inserted to the coronary sinus and the cardioplegia solution was injected.At first, the coronary sinus pressure was indicated as 20mmhg, however the pressure went down to a single digit level.The cannula was removed, and the balloon rupture was confirmed then.At the same time, the patient coronary sinus was also confirmed to be ruptured.The patient coronary sinus was repaired and another rc2012 retrograde cardioplegia cannula was used.The surgery was completed, and the patient status was reported as "under treatment".There was no calcification of coronary sinus.The flow rate of cardioplegic solution was 200 ml/min, but the coronary sinus pressure did not rise, so the flow rate was risen to 300ml/min.The cannula was not manipulated before increasing the flow rate.Total volume of injected cardioplegia before the balloon rupture is unknown.The cannula was inserted when the patient was partially on cardiopulmonary bypass.The location of the tip of the cannula was correct as the surgeon was placing his hand to the patient's heart and checking it by the echo.Balloon inflation test before use was probably not performed.Inconsistencies of the device were probably not noted before use.There was no kink on the cannula.The customer commented that the reason for the coronary sinus rupture whether it was device related or patient/procedural related was unknown.The surgeon was well experienced.The device was stored flat at the hospital.Customer complaint of balloon rupture 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.No other visual damage, contamination, or other abnormalities were found to the device.Based on the morphology of the balloon rupture and the customer's description of the event, it is likely that the root cause is related to use error.The ifu states that "flows in excess of 120 ml/min may result in balloon overinflation and/or coronary sinus injury," and the customer reported a flow rate of 300ml/min prior to rupture.In addition, evaluation by manufacturer viant did not indicate the root cause of the balloon rupture was manufacturing related.Per viant "the dhr investigation does not indicate any nonconformances or deviation associated with balloon rupturing." an edwards/supplier defect has not been confirmed, and no addition action is required by edwards or viant.

• Brand Name: EDWARDS LIFESCIENCES RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13981088
• MDR Text Key: 291850755
• Report Number: 2015691-2022-04781
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103034370
• UDI-Public: (01)00690103034370(17)240618(11)210618(10)2021060853
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

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: RC2012
• Device Lot Number: 2021060853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/07/2022; 06/10/2022
• Supplement Dates FDA Received: 04/14/2022; 06/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention; Hospitalization