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

Model Number ICF100

Device Problem Unable to Obtain Readings (1516)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: no pressure monitoring device was returned with product.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, cardioplegia lumen was found to be occluded with blood.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 min.Without leakage.No other visual damage, contamination, or other abnormalities were found.Udi number: (b)(4).The device was returned to edwards for evaluation.Customer complaint of pressure reading issues was unable to be confirmed.No pressure monitoring device was returned with product.Inability to read pressure in a circuit may have many different causes including problems with the pressure monitor or a leak in the circuit.This typically results in troubleshooting by the team and may require an exchange of catheters.The exchange would occur prior to initiation of therapy and result in a minor delay in treatment of monitor.The cause of the event cannot be determined at this time.Additional investigation is being performed.A supplemental mdr will be submitted as new information is received.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

Edwards received information when using the device balloon there was no root pressure reading.This was a robotic tvr, annular reduction and leaflet accommodation procedure.It was learned there were no issues for approximately 30 minutes then once they inflated the balloon, and noticed there was no drop off of the aortic root pressure.Customer is a frequent use of the device so ew rep confident all troubleshooting techniques relevant to specific issue were performed.Catheter was removed and replaced with another device.Once thee catheter was replaced all pressures were normal.There was no damaging to the packaging.There was no harm to the patient.

Manufacturer Narrative

H10.Additional manufacturer narrative: added information to d4, h4, h6.D4.Udi number: (b)(4) the device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The alleged complaint condition was not able to be confirmed during product evaluation.Root cause cannot be determined at this time.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11072193
• MDR Text Key: 239742984
• Report Number: 3008500478-2020-00217
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1