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

Model Number ICF100

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Udi # (b)(4).The devices has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once the product evaluation has been completed.

Event Description

It was reported that during a mitral valve procedure with mini-sternotomy, the endoballoon of an icf100 floated up and unable to be oriented properly.Per the surgeon, the balloon did not seem parallel with the aorta.The surgeon felt that there may have been a fracture in the catheter.A second icf100 was opened and used and the endoballoon still could not be properly oriented.It was unsure if there was a mechanical problem with the balloon or if the patient had extenuating circumstance unknown to the surgeon.The balloon tip was not against the aorta wall.There did not appear to be any unique anatomy.The balloon was observed in the aortic root on tee.However, the balloon was advanced at the groin all the way to the hub.The patient did not experience any adverse events.The patient was reported to be doing well post procedure.

Manufacturer Narrative

Evaluation summary: device #1: customer report of damaged catheter shaft was not confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the ao root pressure lumen was occluded with blood and unable to be flushed through.All other 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.Device #2: customer report of damaged catheter shaft was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the ao root pressure lumen was occluded with blood and unable to be flushed through.All other through lumens were found to be patent without any leakage or occlusion.As received, the catheter shaft was compressed with a noticeable indentation from the catheter tip to mid-shaft connection.Catheter balloon inflated clear and remained inflated for more than 5 minutes without leakage.No other visual damage, contamination, or other abnormalities were found.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 and deliver antegrade cardioplegia, and vent the heart.In a worst case scenario, a leak in the device could result in blood loss.Per the instructions for use (ifu), "sterile and nonpyrogenic in an unopened and undamaged package.Do not use if the intraclude device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open." in this case, the returned device #1 was found to have no defect and functioned as intended.However, the returned device #2 was observed to have the catheter shaft compressed with a noticeable indentation from the catheter tip to mid-shaft connection.The root cause cannot be determined at this time.It cannot be further ascertained if the damage was sustained during handling/use, shipping or storage, or during manufacturing.Edwards personnel inspect each device for device damage and it is likely that this damage would have been identified at this point.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

Manufacturer Narrative

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

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8344431
• MDR Text Key: 136303865
• Report Number: 3008500478-2019-00106
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2018

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 Expiration Date: 10/15/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 03/20/2019; 07/23/2020
• Supplement Dates FDA Received: 03/21/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1