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

Model Number ICF100

Device Problem Material Rupture (1546)

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

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 root cause cannot be determined with the available information.It is unknown whether patient and/or procedural related factors may have caused or contributed to the event.The subject device has not been returned for evaluation; therefore, the reported event could not be confirmed.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.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received notification of 2 balloon ruptures occurred during the procedure.As reported, the balloon pressure was normal and with no extra volume.The devices were checked before use.Balloon pressure was maintained constant throughout the procedure.Surgeon has got high level of experience.No other details were provided.

Event Description

Edwards received notification of a balloon rupture that occurred during a mvr procedure.The procedure had to be finished with a chitwood clamp.As reported, the balloon pressure was normal and there was no extra volume.The devices were checked before use.Balloon pressure was maintained constant throughout the procedure.The patient was noted to be fine post procedure.Surgeon has got high level of experience.No other details were provided.

Manufacturer Narrative

The subject device was not returned for evaluation as it was discarded at the hospital.

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 root cause has been determined to be related to a supplier manufacturing defect.The supplier has indicated that the issue is currently being investigated.The subject device was not returned for evaluation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues 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 DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8723211
• MDR Text Key: 149081131
• Report Number: 3008500478-2019-00142
• 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,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61898938
• 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