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

Model Number ICF100

Device Problem Material Rupture (1546)

Patient Problem Ventricular Fibrillation (2130)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the balloon bursts 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.A definitive root cause cannot be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that balloon rupture of this clamp occurred during a minimally invasive mitral valve replacement with a non-edwards device.As reported, the customer had tested the device outside the patient's body before use and no issue was observed.The rupture occurred while the surgeon was checking the mitral valve, far from sharp instruments and from the balloon.As per the surgeon, the rupture was not caused by surgical manipulations, neither was the balloon over-inflated or used in other way than prescribed in the ifus.The surgeon managed to complete the procedure with the patient under ventricular fibrillation.After the procedure, the patient was transferred to the icu and was noted as to be fine.

Manufacturer Narrative

H3.Device evaluation: customer complaint of "balloon rupture" was confirmed.As received, the balloon was observed to be ruptured.Edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Updated sections d4 (expiration date), h3, h4, and h6.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.

Manufacturer Narrative

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: 8574724
• MDR Text Key: 144147681
• Report Number: 3008500478-2019-00131
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 07/23/2020
• Supplement Dates FDA Received: 07/03/2019; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR