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

Model Number RC2012

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

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 a procedure, the rc2012 retrograde cardioplegia catheter with a self-inflating balloon had over-expanded and damaged the coronary sinus.

Manufacturer Narrative

H10.Additional manufacturer narrative: attempts to retrieve additional information and device were unsuccessful.The complaint is not confirmed.An edwards/supplier manufacturing defect is not confirmed.A dhr review could not be performed because the lot number is unknown.The investigation is limited because the device was not returned for evaluation and no pictures or medical records were provided.No additional details were able to be obtained from the customer regarding the balloon over-expansion and coronary sinus damage.The complaint is unable to be confirmed and there is no evidence to suggest a design or manufacturing non-conformance.It is possible the sinus pressure and/or the flow indicated in the ifu were exceeded, but, based on the information available, a definitive root cause cannot conclusively be determined.

• 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: 15466621
• MDR Text Key: 300401531
• Report Number: 2015691-2022-08022
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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 Model Number: RC2012
• Device Catalogue Number: RC2012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention