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

Model Number ICF100

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Decrease in Pressure (1490)

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

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was not reviewed as the device lot number was not provided.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.A definitive root cause could not be determined at this time.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that towards the end of a case when a ring was being placed, the pressure of the intraclude balloon was decreasing.It was suspected that the balloon had a small leak as it was a slow progressive volume loss.The surgeon decided to deflate the intraclude balloon.When the balloon was deflated, it was noted to have blood evacuated into the balloon inflation syringe.The team immediately went to fibrillatory arrest and cooled the patient.There was no hemodynamic compromise and the surgery continued without any extra time delay.The patient had an uneventful post operative recovery.The surgeon was utilizing a pr-9 and endovent.Because of the surgical complexity of the case, the surgeon determined that it was necessary to utilize the intraclude balloon.The necklines were placed without complications.The case was started without problems.The aorta measured 3.8 cm.There was no significant calcium noted on the ascending aorta on intra-operative tee.The initial balloon volume was 49cc with an initial pressure reading of 308 mmhg.The balloon pressure decreased to about 250 mmhg but there was no change in root pressure.Towards the end of the case it was noted that the balloon pressure was decreasing.It was suspected that the balloon had small leak as it was a slow progressive volume loss.Loss of occlusion was evident by the rise of the root pressure equivalent to systemic blood flow and from blood filling the left ventricle.No saline was added at any time.At this point the surgeon decided to deflate the intraclude balloon.When the balloon was deflated, it was noted to have blood evacuated into the balloon inflation syringe.The team immediately went to fibrillatory arrest and cooled the patient.There was no hemodynamic compromise and the surgery continued without any extra time delay.Estimated incision time was 10am, and the case finished around 2pm.Of note, this surgical time is consistent with the surgeon's other cases.The patient had an uneventful post operative recovery.The packaging and catheter were discarded.No photos are available.

Manufacturer Narrative

H11.Corrected data - updated section h6 (result).

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: 10208322
• MDR Text Key: 198131571
• Report Number: 3008500478-2020-00199
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• 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
• Patient Outcome(s): Life Threatening; Required Intervention