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

Model Number RC2014

Device Problem Insufficient Information (3190)

Patient Problems Perforation of Vessels (2135); Insufficient Information (4580)

Event Date 04/07/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional 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.H3 other text : device was discarded.

Event Description

It was reported prior to use of a rc2014 retrograde cardioplegia cannula the patient had a perforated coronary sinus complication and received a cabg x 3.The device was discarded post procedure.

Manufacturer Narrative

Attempts have been made to obtain missing information; however, to date, no response has been received.Based on the information available, a definitive root cause cannot be conclusively determined.The device history record (dhr) could not be reviewed, as the device serial number was not provided.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was reported during use of a rc2014 retrograde cardioplegia cannula the patient had a perforated coronary sinus complication and received a cabg x 3.There was no issue with the cannula.The device was discarded post procedure and lot number was not provided and no device photos were taken.

• Brand Name: RETROGRADE CARDIOPLEGIA
• 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: 16892359
• MDR Text Key: 314801572
• Report Number: 2015691-2023-12855
• 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: 06/30/2023

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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 06/30/2023
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 54 KG