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

Model Number ICF100

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

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

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

Additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

Edwards received information that during a right thoracotomy mitral repair and cryomaze ablation, a spontaneous loss of pressure was observed in the intra-aortic occlusion device.The event occurred approximately twenty (20) minutes after initial inflation and placement of the device.The surgeon was placing a stitch into the anterior mitral leaflet when the balloon lost pressure; however, per the edwards representative present, it was clear that the needle was nowhere near the device in the ascending aorta.In addition, the cryo probe was not near the aorta.Balloon pressure before loss of pressure was 320mmhg.The case was continued under fibrillatory arrest and the patient was cooled to 25 degrees celsius.Upon removal of the device, two small leaks were reportedly noted in the surface of the balloon, and blood was found in the balloon.It was also noted no blood was aspirated in the syringe upon deflation of the balloon prior to device removal.No abnormal patient anatomy was noted.There was no patient injury resultant from this event.The patient was off cardiopulmonary bypass and hemodynamically stable after the case.

Manufacturer Narrative

Evaluation summary: the device was received by edwards lifesciences for evaluation and the reported condition was confirmed.As received, the balloon inflated slightly, but failed to maintain inflation due to a pinhole leakage.The device history record (dhr) was reviewed and showed this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.A manufacturing defect was not confirmed.The root cause of the balloon leakage was unable to be determined.The ifu and training manuals were reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; m/s mle 8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5327129
• MDR Text Key: 34359452
• Report Number: 3008500478-2015-00076
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Lot Number: 60147004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 88