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

Model Number ICF100

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190); Physical Resistance/Sticking (4012)

Patient Problem Blood Loss (2597)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

The intraclude is typically used in minimally invasive mitral valve surgery.Its purpose is to: occlude the aorta, keeping the operative field dry, particularly in patients with aortic insufficiency, deliver antegrade cardioplegia, and vent the heart.In a worst case scenario, a leak in the device could result in blood loss.If the leak is significant enough and it requires an exchange of the device after the aortic occlusion or ¿crossclamp¿ is initiated, it results in a change of operative strategy or results in hemodynamic instability requiring blood transfusion.In this case operative strategy was changed to mechanical cross-clamp.The device was not returned for evaluation, as it was reported to be unavailable.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that procedural factors contributed to the event.The device history record (dhr) review is in progress, a supplemental report will be submitted upon completion.

Event Description

It was reported that blood was noticed when surgeon pulled volume from balloon into the syringe during a procedure of mitral valve replacement (thoracotomy) using an intra-aortic occlusion catheter.A mechanical cross-clamp was used and no patient inquiry was noted.As reported, when blowing up the balloon to occlude aorta and arrest the heart, the surgeon pulled volume from balloon into the syringe in order to re-position the balloon for optimal placement.Surgeon mentioned that it might have happened when the balloon was initially passed through the "tuohy-borst valve" on the arterial return cannula.The surgeon noted (in hindsight) that it felt tighter than normal when passing through the side arm.Prior to use the balloon was filled with about 20ml saline and the device was prepared without incidents.When deflating the device to remove so a cross clamp could be used, the pa at the table encountered resistance at the tip of the intra-aortic occlusion catheter and pulled back with a little force and sheared the balloon in half as not all volume was removed prior to removing.

Manufacturer Narrative

The device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the intraclude catheter balloon was torn down the center and edges of catheter balloon appeared to match up (see figure 2).Traces of blood were evident within the intraclude balloon.The balloon inflation lumen and ao root pressure lumens were found to be occluded with blood and unable to be flushed out.The ao root infusion lumen was patent without any leakage or occlusion.No other visual damage or other abnormalities were found.Customer report of balloon leakage was unable to be confirmed due to condition of device as returned.Per the engineering evaluation, a manufacturing defect cannot be confirmed due to the condition of the returned device.The root cause cannot be determined at this time.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.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8181933
• MDR Text Key: 131321770
• Report Number: 3008500478-2018-00097
• 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,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61425734
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1