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

Model Number RC2014MIBB

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2022

Event Type  Injury  

Event 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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 302681186
• Report Number: 2015691-2022-08897
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103034479
• UDI-Public: (01)00690103034479(17)250225(11)220225(10)2022021180
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 10/27/2022; 10/26/2023
• Supplement Dates FDA Received: 11/21/2022; 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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: 74 YR
• Patient Sex: Male