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

Model Number ICF100

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Eccentric balloons may be identified during the prepping procedure.Users are advised per dfu to inflate the balloon with 30 to 40 ml (maximum) of sterile saline to verify proper inflation and balloon shape.Per specification, some degree of eccentricity is acceptable.As long as the balloon is occlusive, eccentricity should not affect the performance of the device.However if it is not occlusive, occlusion of the aorta will not be able to be initiated and a simple device exchange at the beginning of the procedure may be required or it may necessitate a change in operative strategy.A change in operative strategy typically occurs due to unanticipated anatomical or procedural factors and is not related to the device.There may be scenarios where a change in operative strategy is due to a malfunction of the device, in these cases, the potential for injury is not remote.In this case, a cross-clamp was used to arrest the heart.The device was not returned for evaluation at this time.The root cause of the event remains indeterminable.If new information becomes available or the device is returned for evaluation, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device lot 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 an intra-aortic occlusion catheter was used in an excision of a left atrial myxoma and complete occlusion of the aorta was not achieved.A cross-clamp was used and case went well.No patient injury was noted.As reported, the aortic diameter by pre-operative echo measured was 2.45 cm.The team deflated the balloon several times and repositioned the catheter but this did not result in occlusion.Several hundred milliliters of cardioplegia were given and the color flow doppler revealed leaking around the balloon.At one point, there was 35 cc injected into the balloon with a balloon pressure of 535 mmhg.Cross-clamp was done and the heart was arrested as expected.Upon finishing the case, the balloon was inspected.A volume of 35 cc was injected into the balloon and no leakage was noted.However, on close inspection of the balloon, it was noted to be oddly malformed.

Manufacturer Narrative

Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, intraclude balloon was inflated and appeared to be abnormal in shape after inflation (see figures 2 & 3).All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.Engineering task has been opened and assigned for further investigation.See attached evaluation photos.Customer report of abnormal balloon shape was confirmed through product evaluation.Per the engineering evaluation, a manufacturing defect was not confirmed and the root cause cannot be determined at this time.As reported, the catheter shaft was inflated and deflated several times.It is unknown how the device was inspected, tested, and/or handled.It is possible that the issue occurred as a result of use.

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: 7820137
• MDR Text Key: 118746321
• Report Number: 3008500478-2018-00080
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 10/25/2018; 07/23/2020
• Supplement Dates FDA Received: 11/02/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1