MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number ICF100

Device Problems Break (1069); Deflation Problem (1149)

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

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: device evaluation is pending.A supplemental mdr will be submitted when the product evaluation is complete.

Event Description

Edwards received information that during a mitral valve repair procedure, while sewing the ring sutures, the surgeon noticed a mechanical disruption of an intra-aortic occlusion device.The surgeon felt the mechanical disruption was a separation from the inner catheter from the outer wire reinforced coverage.The issue was noticed approximately 60 minutes after occlusion.The balloon pressure dropped and blood was noticed in the operating field.It was noticed the balloon moved towards the aortic root.The surgeon elected on completing the case with a fibrillating heart and deflated the balloon.It was reported the balloon was not punctured by a needle.The device was used according to the instructions for use and a total of 35 ml of volume was used to inflate the balloon.The surgeon is an experienced user of this product.There were no injuries or no negative outcomes due to this event.The patient was last reported to be hospitalized in stable condition.

Manufacturer Narrative

The device was not returned to edwards for evaluation and the reported complaint conditions of mechanical disruption and improper balloon occlusion was unable to be confirmed.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.A manufacturing defect was not confirmed.Base on the information received, a definitive root cause could not be determined.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.(b)(4).

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; ms mle-8; irivne, CA 90621 ; 9492502289
• MDR Report Key: 5254283
• MDR Text Key: 32293261
• Report Number: 3008500478-2015-00072
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2017
• Device Model Number: ICF100
• Device Lot Number: 59979641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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 Age: 60 YR
• Patient Weight: 100