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

Model Number RC2012

Device Problems Use of Device Problem (1670); Material Deformation (2976); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2022

Event Type  Injury  

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.

Event Description

It was reported that during use of a rc2012 retrograde cannula it was noted that the device was not working properly.The metal portion of the rc2012 went through the balloon part.Due to this occurrence the surgeon requested ostial cannulas.

Manufacturer Narrative

Updated h3 and h6 per new information received.Customer report of metal portion of the rc2012 went through the balloon part was confirmed.Device was returned with visible traces of blood.As received, malleable stylet was inserted in the cardioplegia cannula and appeared bent.Stylet extended 7mm at the distal end through one of the three infusion hole.Infusion hole appeared to be intact.Resistance was met when stylet was removed from the cannula.The balloon inflated without difficulty.All other through lumens were patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found to the device.

Event Description

It was reported that during use of a rc2012 retrograde cannula it was noted that the device was not working properly.The metal portion of the rc2012 went through the balloon part.Due to this occurrence the surgeon requested ostial cannulas.Product eval showed infusion hole appeared to be intact.Resistance was met when stylet was removed from the cannula.The balloon inflated without difficulty.Lumens were patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found to the device.

Manufacturer Narrative

Dhr review was performed, and no relevant non-conformances were identified.Based on the information available the complaint is able to be confirmed.It is likely that the observed damage to the device is due to the user exerting excessive force during stylet insertion into cannula.It is unlikely that the product left the manufacturing facility in the observed state furthermore, the damage was not noticed prior to the procedure.The lhr performed does not suggest a lot specific non-conformance.An edwards defect has not been confirmed.

• Brand Name: RETROGRADE CORONARY SINUS CARDIOPLEGIA CANNULAE
• 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; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15485527
• MDR Text Key: 300583546
• Report Number: 2015691-2022-08076
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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?: Yes
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Device Lot Number: 2021120789
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 04/04/2023; 10/05/2023
• Supplement Dates FDA Received: 04/27/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other