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

Model Number ICF100

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.

Event Description

It was reported that an intraclude device lost pressure during a case.A small pinhole was noted on the balloon surface when it was tested after the case was finished.Patient was reported to be fine.As reported, no abnormality was noted during preparation.The intraclude was placed and ~28 ml of fluid was used to occlude the aorta (within 3.0 cm aortic stent graft).Initial balloon pressure was 370 mmhg.Root pressure went down and internal balloon pressure went to approximately 360 mmhg prior to bypass.After a few minutes of occlusion, the balloon pressure dropped to under 300, then a few minutes later to ~200 mmhg.The surgeon noted that and he didn¿t believe the balloon was holding fluid so the pa watched the balloon pressures and ended up adding 2-3 ml of fluid to the balloon to maintain an internal pressure of ~275 mmhg.This occurred every few minutes for more than 10 times, but they were able to maintain aortic occlusion.When deflating the balloon, red hued saline was returned to the syringe and blood was seen in the surgical field.This was a (b)(6) female patient who underwent a surgery for a thoracic aneurysm, the 4th procedures that patient had.

Manufacturer Narrative

The device was returned with visible traces of blood and was examined in the biohazard area of the lab.Intraclude balloon was observed to have a pin hole leakage when inflated.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Edwards received additional information through follow up with the healthcare provider.Updated.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.Customer report of loss of balloon pressure was confirmed with observed balloon pin hole leakage.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.The root cause of the event remains indeterminable.If new information is received, a supplemental report will be submitted.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.

Manufacturer Narrative

Based on the engineering evaluation, a manufacturing defect was not confirmed.The end user reported that the icf100 balloon had to pass through thoracic stent grafts in order to migrate to the aorta.This could have potentially caused the balloon damage.However, the root cause cannot be determined at this time.

Manufacturer Narrative

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

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine 92614
• MDR Report Key: 7707051
• MDR Text Key: 114940218
• Report Number: 3008500478-2018-00076
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K132175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2018

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: 02/07/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61259629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 09/24/2018; 07/23/2020
• Supplement Dates FDA Received: 08/28/2018; 09/25/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 97