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

Model Number ICF100

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Additional 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.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.In this case, the balloon required continuous addition of saline to be able to maintain balloon pressure.The root cause of this event cannot be conclusively determined with the available information.The subject device is not available for evaluation.The device history record (dhr) could not be reviewed, as the device serial number was not provided.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that during a procedure the endo balloon of an edwards intra-aortic occlusion catheter leaked throughout the entire case.The surgical staff was required to continuously add saline to the balloon.No additional details were provided.

Manufacturer Narrative

Evaluation summary: customer complaint of leakage was not confirmed with assessment.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.All through lumens were found to be patent without any leakage or occlusion.Catheter balloon inflated clear and remained inflated for more than 5 minutes without leakage.No other visual damage, contamination, or other abnormalities were found.

Manufacturer Narrative

The subject device was returned for evaluation.The root cause cannot be determined with the available information at this time.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak pkwy; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7129701
• MDR Text Key: 95343205
• Report Number: 3008500478-2017-00051
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132175
• 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,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• 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