MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE; CLAMP, VASCULAR

Model Number ICF100

Device Problems Break (1069); Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

Edwards received notification that at the end of a chordae replacement and ring implant surgery, using a vascular clamp device, the balloon bursted.Surgery was performed by atriotomy.As reported, the balloon pressure maintained constant throughout the procedure.The event occurred during closure of the atrium.At the point of the balloon burst, the pressure dropped rapidly.There was no significant prolongation in surgical/bypass time due to this issue.The patient was noted as to be fine.Surgeon was noted as to be very experienced in using the device.

Manufacturer Narrative

Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8375503
• MDR Text Key: 138102409
• Report Number: 3008500478-2019-00109
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61723505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1