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

Model Number ICF100

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Therefore, the reported event could not be confirmed.The root cause of this event cannot be conclusively determined with the available information.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

As reported, the intraclude catheter was noticed to be leaking air upon preparation of the balloon.As reported, air bubbles continued to be drawn during the de-airing of the balloon process.No damage to the packaging of the device was noted.The device was prepared per the ifu.The device was not introduced to the patient and a new one was prepared.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated section h4.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Manufacturing, supplier, design, ifu, and labeling defects were not confirmed.Trend is in control.Capa and pra action are not required.Root cause cannot be determined at this time.Trends will continue to be monitored through the use of edwards quality systems.

Manufacturer Narrative

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: 8368516
• MDR Text Key: 137542298
• Report Number: 3008500478-2019-00107
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61097633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1