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

Model Number	RC2014S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: additional manufacturer narrative: per the engineering evaluation and investigation, no product evaluation could be performed as the product was not returned.A dhr review was conducted and confirmed all validated processes and parameters were followed during the manufacturing of the suspect device lot.There were no nonconformances or deviations associated with this lot.The incoming inspection records were reviewed for the device tubing and there were no visual or dimensional nonconformances.Mitigations are in place at the supplier including a 100% visual inspection tip smoothness, tip cracking, tip deformation, and catheter melt.Based on the information provided, the rc2014s may have been used for suction, as the event description refers to the tip as a "suction tip." this would be considered off-label and abnormal use of the device.The instruction for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Due to limited information available for the report incident, a definitive root cause of the reported event cannot be conclusively determined.An edwards/supplier defect has not been confirmed.This event was reported to the fda as mdr-30 day reportable with reference number (b)(4) in relation to the distributor kit model dynj76106c cabg-pump-lf which includes the rc2014s.Report mw5159684 is referenced as part of that report.No additional information was provided.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 or Problem Description
Edwards was notified of a complaint from a customer stating suction tip broke during a procedure.The tip was reported to have come off in the chest cavity of the patient.The tip was retrieved and confirmation of removal of pieces was completed by the surgical staff.The failure was reported to be with rc2014s from lot 2023051119.The device is not available for return.Patient impact and status are unknown.This event was reported to the fda as mdr-30 day reportable with reference number (b)(4) in relation to the distributor kit model dynj76106c cabg-pump-lf which includes the rc2014s.Report mw5159684 is referenced as part of that report.No additional information was provided.

• Brand Name: RETROGRADE CORONARY SINUS CARDIOPLEGIA CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8018424930
• MDR Report Key: 21339755
• Report Number: 2015691-2025-00878
• Device Sequence Number: 8432012
• Product Code: DWF
• UDI-Device Identifier: 00690103034486
• UDI-Public: (01)00690103034486(17)260519(11)230519(10)2023051119
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2026
• Device Model Number: RC2014S
• Device Lot Number: 2023051119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown