MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

Model Number ICF100

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

Event Type  Injury  

Event Description

Edwards received notification that issues were experience with an intraclude device.As reported, during a mini-mitral valve repair procedure the blue pressure line of the luer lock went off and the pressure of the balloon dropped suddenly to zero and the balloon got empty.This caused the heart to beat during the procedure and additional cardioplegia was required for the patient.As reported, after the balloon emptied it was refilled and the procedure went fine.

Manufacturer Narrative

The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the intraclude balloon is not totally occlusive during a procedure, the heart would fill and warm, the operative site may be obscured and the procedure may need to convert to an open procedure.The device is in the process of being returned.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Edwards received notification that issues were experience with an intraclude device model.As reported, during a mini-mitral valve repair procedure the blue cable was detached from the connection during the procedure and the pressure of the balloon dropped suddenly to zero and the balloon got empty.The blue tubing got pulled out from the male luer lock.No saline leaking occurred due to the detachment.This caused the heart to beat during the procedure and additional cardioplegia was required for the patient.The surgeon re-plugged it, closed the blue stopcock entirely and refilled the balloon and proceeded with the procedure without complications.When the surgeon re-plugged it there was no leak at the blue pressure line/male luer lock.Per image provided it pointed to the connection point between the blue tubing and the male luer lock.

Manufacturer Narrative

H10: additional narratives.Updated b5 per new information received.

Manufacturer Narrative

Based on the information available, a root cause cannot be conclusively determined at this time.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14086415
• MDR Text Key: 289098634
• Report Number: 2015691-2022-04996
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132175
• 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,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization