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

Model Number ICF100

Device Problems Leak/Splash (1354); Decrease in Pressure (1490); Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned for evaluation.Device evaluation anticipated, but not yet begun.A supplemental report will be submitted once the evaluation has been completed.

Event Description

It was reported that during a mini mitral repair, the icf100 intraclude device had started to lose pressure towards the end of the case.The decision was made to not cross-clamp and the heart was allowed to fibrillate until completion.Post procedure the balloon was checked and a small hole was observed on the side of the balloon.The patient was reported to be stable and doing well.Additional information received indicated that the nurse scrub confirmed there was no leak visible when she prepared it.The nurse had to add volume to the balloon throughout the duration of the case.She could not tell how much.They routinely kept the balloon at 20cc's, no more.The surgeon shared that at 20cc's, they could not see a leak in the balloon, as the nurse preps routinely, but after the case they did see a leak after putting 25cc's of fluid in the balloon.

Manufacturer Narrative

Evaluation summary: customer report that "small hole was observed on the side of the balloon" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Balloon failed to maintain inflation due to a pin hole leakage.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.The root cause of this event remains indeterminable with the available information.There were no issues identified with the manufacturing, supplier or design of this product.There were also no issues with the instructions for use or labeling of the device.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 lifesciences will continue to monitor all reported events.No further actions are required at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• 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: 8527779
• MDR Text Key: 142884864
• Report Number: 3008500478-2019-00124
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61713205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention