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

Model Number ICF100

Device Problem Material Rupture (1546)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the balloon bursts during a procedure, the heart would fill and warm, the operative site may be obscured and the procedure may need to convert to an open procedure.In this case, the patient was noted to be fine.This device was not returned for evaluation at this time and follow up is in progress.The investigation is on-going and a supplemental report will be submitted upon receipt of additional information.

Event Description

Edwards received information that the balloon of an intra-aortic occlusion catheter ruptured during use.The patient was noted to be fine.No additional details were provided.

Manufacturer Narrative

The device was returned for evaluation and the customer complaint of balloon rupture was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Balloon was observed to be ruptured.Edges of rupture site appeared to match up.As received, the ao root infusion was occluded with blood.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Per the engineering evaluation, a supplier manufacturing defect was confirmed.A manufacturing, design, ifu, and labeling defect were not confirmed.The root cause will be investigated in within the edwards quality system.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRA CLUDE 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: 8833934
• MDR Text Key: 152789879
• Report Number: 3008500478-2019-00155
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61979877
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1