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

Model Number ICF100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/18/2017

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.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.The device was not returned for evaluation, at this time.In this case, minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device and patient's medical history has been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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.

Event Description

It was reported that this intra-aortic occlusion catheter leaked during a surgery.The surgeon stated it seems to be leaking mid-shaft.No additional information was provided.

Manufacturer Narrative

Evaluation summary: device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the catheter shaft was found compressed/flattened in two directions at the distal section near the balloon.The device started leaking at the mid-shaft connection area when inflating the balloon inflation lumen with water.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.Per the supplier investigation, a small hole was found in the shaft wall of the inflation lumen just proximal of the distal end of the hub.Per the product evaluation, the customer complaint of leakage from mid-shaft area was confirmed.Per the supplier investigation, the small hole was caused by a compressed strain relief pushing material into the shaft wall as result of the material flow during injection molding of the hub.The product failure was assumed to be initiated during manufacturing and is product related.Per the engineering evaluation, a supplier manufacturing defect was confirmed.A design, ifu, and labeling defect was not confirmed.The trend was reviewed and found to be in control and the fmea line item is appropriate.Appropriate action has been initiated.

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7186715
• MDR Text Key: 97514142
• Report Number: 3008500478-2018-00055
• 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
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• 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?: Yes
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention