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

Model Number ICF100

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/31/2017

Event Type  Death  

Manufacturer Narrative

The event states death and the cause of death is unknown or not provided.Although the vast majority of these events are most likely not related to the device.In this case, minimal information regarding this event was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful at this time.The root cause of the event remains indeterminable.If new information becomes available, 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

Edwards received information that a patient expired following a robotic mitral valve replacement where an intra-aortic occlusion catheter was used.No other information was provided.

Manufacturer Narrative

Edwards received additional information through follow up with the healthcare provider.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that procedural factors contributed to the event.

Event Description

Edwards received additional information through follow up with the healthcare provider.The exact date of death was unknown.As reported, the surgeon believed that his management and operation of the catheter was to blame for the complications and not the device itself.The device was not able to be returned as it was discarded.No additional details were provided.

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; m/s mle 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6836128
• MDR Text Key: 84299175
• Report Number: 3008500478-2017-00044
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death