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

Model Number ICF100

Device Problem Hole In Material (1293)

Patient Problem Not Applicable (3189)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available for evaluation as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.A definitive root cause cannot be determined as this time.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warnings and cautions: "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.Always wet the balloon surface with sterile physiologic solution prior to insertion to facilitate intraclude device introduction through the hemostasis valve or damage to the intraclude device may occur.A loss of occlusion (evident by blood in the surgical field and/or a rise in aortic root pressure) along with a significant loss of pressure within the balloon may indicate compromised balloon integrity.Completely deflate the balloon and remove the intraclude device carefully according to the withdrawal instructions to reduce the risk of patient injury.Do not add volume to the balloon based on a gradual balloon pressure drop as bursting of the balloon can occur.A gradual balloon pressure drop is normal, due to material relaxation of the balloon, and does not indicate loss of occlusion in the aorta." edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

Edwards received information that the customer experience a drop of balloon pressure with balloon rupture during a mvr case.The subject device was prepared without any abnormalities noted.Thirty six milliliters of volume was added to the balloon initially.Then another 14 ml was added throughout the case.A gradual drop of pressure was noted; however, faster than normal.Immediately, the surgeon occluded the aorta with a chitwood clamp without sternotomy to complete the case.The patient developed transient ischemic attack (tia) postoperatively.The patient later expired.Per the surgeon, the tia was not related to the issues experienced on the subject device.The surgeon and the surgical staff disassociate the final outcome from the subject device.

Manufacturer Narrative

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.Per the engineering evaluation, a manufacturing defect was not confirmed.As reported, 36 ml of volume were added to the balloon initially and another 14 ml were added throughout the case, exceeding the maximum recommended volume.This may have caused or contributed to the reported balloon rupture; however, the device was not returned and a definitive root cause could not be determined.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7530437
• MDR Text Key: 109064500
• Report Number: 3008500478-2018-00069
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

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: 12/07/2019
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61184967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1