MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number ICF100

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

The explanted valve has been returned for evaluation.Device evaluation anticipated, but not yet begun.A supplemental report will be submitted once the evaluation has been completed.

Event Description

It was reported that the balloon leaked from the tip of the icf100 intraclude device.The balloon itself remained intact.It was indicated that the surgical staff tried to limp through the procedure, but had to continuously add volume, as it would not hold a seal.Therefore, the device was removed and the chitwood clamp was applied, and the case was completed.Upon removal, the balloon was inspected and found to leak out of the tip.The size of the aorta is unknown.The total inflation volume was per ifu recommendation.The balloon pressure was maintained usually around 300.It is unknown how much saline was added to maintain pressure.The amount of calcification is unknown.The patient was reported to be fine.

Manufacturer Narrative

Customer complaint of balloon inflation issue was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Traces of blood were evident within the intraclude balloon.The intraclude balloon would not maintain any inflation at all due to interlumen leakage between the inflation lumen and the ao root infusion lumen.X-ray revealed that the core wire had dislodged from the intraclude hub to approximately 1" distal from the intraclude hub.Interlumen leakage was found to occur at the dislodged core wire location.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.The root cause of this event remains indeterminable at this time.There were no issues identified with the manufacturing, supplier or design of this product.There were also no issues with the instructions for use (ifu) or labeling of the device.Per the ifu, "care should be used when handling the devices.Damage may result from kinking or stretching the devices.Do not use the device if kinked as this may result in inability to deflate the balloon or other device failures." also, "check the balloon prior to insertion to ensure that a vacuum has been maintained.A loss of balloon vacuum indicates that there is a leak in the system which may result in unexpected balloon deflation and loss of aortic occlusion.If a leak is detected, replace the intraclude device or leaking component prior to use." additional instructions are provided for priming the balloon and the lumen prior to use.Users are also advised to, ¿[¿] clamp the non-reinforced section of tubing attached to the hemostasis valve of the cannula¿ and ¿[¿] do not over tighten the cannula hemostasis valve in order to prevent crushing of the intraclude device.¿ the device history record (dhr) could not be reviewed, as the device lot number was not provided.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8981857
• MDR Text Key: 207055756
• Report Number: 3008500478-2019-00157
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1