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 08/31/2017

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.In this case, the surgeon was able to continue closing the left atrium with a beating heart.The patient was successfully weaned from bypass.The device has not been returned for evaluation; therefore, the reported event cannot be confirmed.The device history record (dhr) review cannot be performed, as the lot 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

It was reported that during a robotic redo mitral valve repair, an edwards intra-aortic occlusion catheter was found to have a leak in the balloon.As reported, the catheter was prepared and placed per the ifu.The surgeon inflated and positioned the catheter into the ascending aorta and achieved adequate occlusion.Antegrade cardioplegia was administered and cardiac arrest was accomplished without incident.The mitral valve was removed and a mechanical valve was implanted.Upon closing the left atriotomy, there was a sudden loss of aortic occlusion and the aortic root pressure rose significantly.Per the operative report, the balloon "the endo balloon appeared to develop a leak and the pressure dropped and we noticed a fair amount of blood coming into our face from the ai.We were able to control the ventricle with a vent across the valve, but it made it somewhat challenging, but we were able to do it.The endo balloon was actually just pulled back." the surgeon was able to continue closing the left atrium with a beating heart.The patient was successfully weaned from bypass.Once the catheter was removed from the patient, it was inflated with fluid on the sterile field and a leak was noted in the balloon.It was clear that this could not have been caused by a needle puncture due to the timing of the event as the suture was being placed in the left atrium far away from the location of the catheter.The operating surgeon is a very experienced and has been a user of the device for several years.Balloon inflation volume was 37cc and was inflated using the supplied syringe.There was no calcification noted in the aorta and no additional volume was added during the procedure.

Manufacturer Narrative

Although the reported event was confirmed, the investigation could not conclusively determine the root cause.

Manufacturer Narrative

Customer complaint that "intraclude was found to have a leak in the balloon" was confirmed.The device was returned with visible traces of blood and examined in the biohazard area of the lab.The balloon failed to remain inflated due to a pin hole rupture.A root pressure lumen was found to be occluded with blood.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Additional information was received from the customer and the following sections were updated.

Event Description

It was reported that during a robotic redo mitral valve repair an edwards intra-aortic occlusion catheter was found to have a leak in the balloon.As reported, the catheter was prepared and placed per the ifu.The surgeon inflated and positioned the catheter into the ascending aorta and achieved adequate occlusion.Antegrade cardioplegia was administered and cardiac arrest was accomplished without incident.The mitral valve was removed and a mechanical valve was implanted.Upon closing the left atriotomy there was a sudden loss of aortic occlusion and the aortic root pressure rose significantly.Per the operative report, the balloon "the endo balloon appeared to develop a leak and the pressure dropped and we noticed a fair amount of blood coming into our face from the ai.We were able to control the ventricle with a vent across the valve, but it made it somewhat challenging, but we were able to do it.The endo balloon was actually just pulled back." the surgeon was able to continue closing the left atrium with a beating heart.The patient was successfully weaned from bypass.Once the catheter was removed from the patient it was inflated with fluid on the sterile field and a leak was noted in the balloon.It was clear that this could not have been caused by a needle puncture due to the timing of the event as the suture was being placed in the left atrium far away from the location of the catheter.The operating surgeon is a very experienced and has been a user of the device for several years.Balloon inflation volume was 37cc and was inflated using the supplied syringe.There was no calcification noted in the aorta and no additional volume was added during the procedure.Post operatively, the patient remained hemodynamically and clinically stable.The patient was discharged in good condition on pod #16.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6892266
• MDR Text Key: 89388536
• Report Number: 3008500478-2017-00047
• 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
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• 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: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• 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 Age: 62 YR