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

Model Number ICF100

Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)

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

Event Date 11/12/2018

Event Type  malfunction  

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.Changes in vascular tone may result in variations of balloon occlusion pressure.It is not unusual for the surgical teams to have to add volume during the case to ensure occlusion.If this routine trouble shooting is unsuccessful and a change in operative strategy (the placement of an external cross clamp, having to exchange the device after bypass is initiated) is required, this event will be reportable.In this case, the balloon was deflated and the occlusion was lost.The device was required to be exchanged.The device evaluation is anticipated, but not yet begun.The device history record (dhr) review is in progress.A supplemental report will be submitted upon evaluation and dhr completion.

Event Description

It was reported that the balloon of a intra-aortic occlusion catheter was deflated and the occlusion was lost within 1-2 minutes.Intraclude was placed in patient aorta via echo.The device was replaced with a new intra-aortic occlusion catheter and used without difficulty.No patient injury was noted.As reported, no leak or accidental puncture to the balloon was noticed.

Manufacturer Narrative

Customer complaint that "balloon of icf100 was deflated and the occlusion was lost within 1-2 minutes" was not confirmed.The device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the returned intraclude device had several kinks along the catheter shaft and near the intraclude hub.All through lumens were found to be patent without any leakage or occlusion.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.No other visual damage, contamination, or other abnormalities were found.Based on the engineering evaluation, the clinical failure cannot be confirmed.Complaint condition of balloon, occlusion difficulty was not confirmed upon assessment.Damage to the catheter was identified during the evaluation.This damage may have contributed to the alleged occlusion issues.Engineering personnel cannot confirm this complaint.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.

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 CA 92614
• MDR Report Key: 8143943
• MDR Text Key: 130185366
• Report Number: 3008500478-2018-00095
• 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
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61531655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1