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

Model Number	RC2014MIBB
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon of a retrograde cardioplegia catheter did not fully expand on one side of the catheter during cardiac bypass.The surgeon had to switch with another device.No patient injury was noted.
Additional Manufacturer Narrative
Additional narratives the retrograde cannula is used intermittently to deliver retrograde cardioplegia administration during cardiac surgery.If a leak is not noticed during the routine flushing of the device during preparation; exchange to an unaffected device could easily be done during the case since cardioplegia is delivered intermittently and the catheter is easily accessible due to the accessibility of the device and the cardiac structures.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Additional Manufacturer Narrative
H10: additional narratives.Updated h3 and h6 per new information received.H3: product evaluation.Customer report of balloon of a rc2014mibb retrograde cardioplegia catheter did not fully expand on one side was confirmed.As received, the balloon was inflated with 5ml of air per ifu without leakage.However, balloon aneurysm was observed.All through lumens were patent without any leakage or occlusion.No visible damage was observed from returned device.
Additional Manufacturer Narrative
Based on the available information the complaint is able to be confirmed however, a definitive root cause cannot be conclusively determined.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: EDWARDS MANUALLY INFLATING RETROGRADE CARDIOPLEGIA CATHETER
• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15691654
• Report Number: 2015691-2022-08897
• Device Sequence Number: 12580892
• Product Code: DWF
• UDI-Device Identifier: 00690103034479
• UDI-Public: (01)00690103034479(17)250225(11)220225(10)2022021180
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2025
• Device Model Number: RC2014MIBB
• Device Catalogue Number: RC2014MIBB
• Device Lot Number: 2022021180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 10/26/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/21/2022; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male