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

Model Number	RC2014
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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.
Event or Problem Description
It was reported a rc2014 burst in the patient and created a hole in the heart.Per the perfusionist, the retrograde cannula was either frozen or burned during a maze procedure.Perfusionist notified physician of high-pressure with low flow (less than 30cc/min) while delivering retrograde cardioplegia into coronary sinus with the tip frozen/burnt caused occlusion of tip of the cannular which caused the catheter to rupture.The patient required a bovine pericardial patch to repair damage cause by the cannula rupturing.It is unknown now long the cannula was in place at time of rupture.No aseptic solution or cleaning agent was used on the device.There was no manipulation of the cannula when the leak occurred.
Additional Manufacturer Narrative
H6- conclusion code- cause traced to another device.The device was not returned for evaluation, however one color image was provided showing the tips of two used devices.The reported damage and occlusion is unable to be confirmed via evaluation of the image.Based on the provided information, the most likely cause of the reported burst is damage caused by another device.
Event or Problem Description
It was reported a rc2014 burst in the patient and created a hole in the heart.Per the perfusionist, the retrograde cannula was either frozen or burned during a maze procedure.Perfusionist notified physician of high-pressure with low flow (less than 30cc/min) while delivering retrograde cardioplegia into coronary sinus with the tip frozen/burnt caused occlusion of tip of the cannular which caused the catheter to rupture.The patient required a bovine pericardial patch to repair damage to the organ caused by the cannula rupturing.The patient was discharged from hospital.
Additional Manufacturer Narrative
Added information to a2, a3, b5.

• Brand Name: RETROGRADE CARDIOPLEGIA CANNULA
• 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17031634
• Report Number: 2015691-2023-13323
• Device Sequence Number: 7012389
• Product Code: DWF
• UDI-Device Identifier: 00858480007138
• UDI-Public: (01)00858480007138(17)260111
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 01/11/2026
• Device Model Number: RC2014
• Device Lot Number: 2023010317
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 08/21/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/29/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male