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

Model Number ICF100

Device Problem Material Rupture (1546)

Patient Problems Failure of Implant (1924); Blood Loss (2597)

Event Date 06/25/2019

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, all fragments were able to be retrieved the patient was reported to be doing fine.Follow up for the device is still in progress and the investigation is pending.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that the balloon of an intra-aortic occlusion catheter ruptured during use.As reported, the patient¿s aorta size was 3.2 and there was no a high amount of calcification.The total inflation volume was not provided.The surgical team struggled with getting complete occlusion throughout the entire case and bleeding was noticed.The balloon was not repositioned during the case.There were no sewing sutures near the balloon when the rupture occurred.The balloon pressure was maintained in the 200-250 range which was also the internal pressure prior to rupture.The duration of use prior to the balloon burst was unknown.The surgeon waited until the repair was done before adding volume to the balloon.The balloon rupture immediately after 2cc of saline was added.All fragments were able to be retrieved.The team was able to finish the case without additional clamping.The patient was reported to be doing fine.

Manufacturer Narrative

As received, the device was returned with visible traces of blood and was examined in the biohazard area of the lab.Balloon was observed to be ruptured (see figure 2).Edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Per the product evaluation, the customer complaint of balloon rupture was confirmed.Per the engineering evaluation, a supplier manufacturing defect was confirmed.A design, ifu, and labeling defect were not confirmed.The trend is in control and the fmea line item is appropriate.A pra was initiated and the root cause will be investigated in the capa.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: 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: 8808390
• MDR Text Key: 151859787
• Report Number: 3008500478-2019-00154
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 07/23/2020
• Supplement Dates FDA Received: 09/24/2019; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1