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

Model Number ICF100

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that the customer had issues with reading the root pressure with an icf 100 intraclude device.All the troubleshooting steps related to that particular issue were performed, but with no resolution.The intraclude catheter was removed and replaced it with a new one and had no issues.No harm was done to the patient.This account does 6-8 cases a month using this product and has done so for over 15 years.They are very experienced in troubleshooting all issues related to this product.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

H3: evaluation summary: customer report of root pressure reading difficulty was unable to be confirmed.All components were attached prior to lumen testing and balloon inflation.Catheter balloon inflated clear without difficulty and remained inflated.Catheter balloon was able to be deflated without difficulty.All through lumens were found to be patent without any leakage or occlusion.As received, traces of unknown green gelatinous material were visible within the balloon.No other visual damages or abnormalities were found.

Manufacturer Narrative

It is unclear from the complaint analysis where this leak is coming from.The leak was not discovered during product evaluation of the complaint at edwards.The dimension of the leak is very small and in such direction that it could only be created by something very small and sharp, and very unlikely to be caused by a guidewire or mandrel used during either manufacturing or the clinical procedure.Air bubbles in the hub were seen in the past, caused during hub molding, which might be a reason for the leak.However, the size and shape of such an air bubble was never seen before.Besides it should have been detected during the in-line leak testing in manufacturing.A dhr review was performed, and no relevant non-conformances were identified.Based on the information available the complaint is able to be confirmed however, a definitive root cause is unable to be determined.It is unclear if a non-conformance originating from supplier manufacturing contributed to the customer's experience.No patient harm occurred as a result of this event.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15303259
• MDR Text Key: 301014721
• Report Number: 2015691-2022-07536
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1