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

Model Number RC2012

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the balloon of rc2012 retro cannula got ruptured during use.The pressure did not rise therefore the cannula was removed from the patient and the balloon rupture was noticed.The cannula was replaced with a new rc2012.There is no patient adverse event reported.The patient status was reported as recovered.The device was stored flat at the hospital.

Manufacturer Narrative

The device was returned to edwards for evaluation.H3.Device evaluation: customer complaint of balloon rupture was confirmed.Balloon failed inflation test due to a balloon rupture.As received, edges of rupture site were unable to match up.What appeared to be dark burn marks were observed along the edges of the rupture site.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found to the device.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Added information to h6.The complaint is able to be confirmed via returned product evaluation.There is no evidence to suggest an edwards manufacturing defect.A device history record (dhr) review was performed, and no relevant non-conformances were identified.Per supplier nvestigation- a review of the finished good dhr indicates that all validated processes and parameters were followed during the manufacturing of this device lot.This includes a 100% leak and flow test, which would not have allowed this defect to pass.No non-conformances or deviations were associated with this lot.A review of the balloon component dhrs indicates that all validated processes and parameters were followed during the manufacturing of this component lot.This includes a 100% double wall thickness check and 100% visual inspection for defects, including aneurysms or pregnancies.This defect would not have been allowed to pass through these checks.No non-conformances or deviations were associated with these lots.Based on the information received, the complaint cannot be confirmed to be related to manufacturing issues.Markings consistent with burns were observed along the edges of the rupture site.Based on the information available the most likely root cause of the reported event is that it occurred during customer use or handling.It is likely that the balloon came into contact with a heated device or electrical instrument resulting in observed damage.No manufacturing deficiencies that could have contributed to this event have been identified.If this damage was present prior to use it would have been identified during balloon preparation.

• Brand Name: 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18371245
• MDR Text Key: 331082663
• Report Number: 2015691-2023-18657
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Model Number: RC2012
• Device Lot Number: 2022101416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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