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

Model Number	FEMII
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it was reported to be unavailable.Attempts to retrieve additional 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
Edwards received information a venous femii (model number unknown) was leaking.It was reported the patient was taken back to the or next day for cannula change.Patient required multiple transfusions.The fluid leaking where the two connections are fused molding leak.Device is not available.
Additional Manufacturer Narrative
Added information to d4.Report of cannula leak could not be confirmed through image evaluation.Three images were provided.The images showed a cannula, and pouch packaging label from model vfem018, lot number 63244118.Blood was visible on the cannula.
Additional Manufacturer Narrative
Complaint was unable to be confirmed.Dhr review was performed, and no relevant non-conformances were identified.Based on the information provided the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.An edwards defect has not been confirmed.The images provided by the customer do not depict a confirmable leak from the device as reported in the event description.Per the event description the device was used on vv ecmo and for greater than 6 hours.The ifu states, edwards lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term less than or equal to 6 hours cardiopulmonary bypass.Vessel access (venous or arterial) is left to the discretion of the physician.Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy.Please consult labeling to determine pressure drop related to flow rates.Femoral access cannulae are contraindicated for long-term use greater than 6 hours, including extra corporeal membrane oxygenation procedures.This device is not intended for use other than as indicated and should not be used when any physical impairment would contraindicate its use.Based on the above information this procedure is considered off-label.

• Brand Name: FEM-FLEX II FEMORAL VENOUS 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: 16713519
• Report Number: 2015691-2023-12233
• Device Sequence Number: 1791566
• Product Code: DWF
• UDI-Device Identifier: 00690103146646
• UDI-Public: (01)00690103146646(17)230611
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K200358
• 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): 11/19/2023

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: 06/11/2023
• Device Model Number: FEMII
• Device Lot Number: 63244118
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 11/02/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/12/2023; 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown