MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FEM-FLEX II FEMORAL ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	FEMII016A
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had bilateral lung transplant and required vv ecmo [veno-venous extracorporeal membrane oxygenation].Around 12 hours later, the canula was found to be cracked and the patient needed to go back to the or for exchange leading to a cardiac arrest and conversion to central ecmo.

• Brand Name: FEM-FLEX II FEMORAL ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 24114649
• Report Number: 24114649
• Device Sequence Number: 17627512
• Product Code: DWF
• UDI-Device Identifier: 00690103031232
• UDI-Public: (01)00690103031232
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/17/2025
• Report Date (Section F): 12/17/2025

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: FEMII016A
• Device Catalogue Number: FEMII016A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/17/2025