MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE; CLAMP, VASCULAR

Model Number ICF100

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Pressure Problem (3012)

Patient Problem Rupture (2208)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.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.A definitive root cause could not be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that during a mini-thoracotomy mitral procedure, the balloon of an icf100 burst and surgeon had to use a chitwood clamp to complete the procedure.As reported, the balloon was not overinflated, they inflated about 50 ml.The aorta was round about 32 mm.At the time of the burst no manipulation/stitching was done near the balloon, the surgeon was working with loops on the leaflets.As reported, before the balloon burst, the pressure was lost several time and they had to add volume to maintain pressure between 300 and 350.The device was tested before use and found to be ok.At the end of the case, the patient was noted as to be fine.Surgeon is very experienced in using the product.

Manufacturer Narrative

Device evaluation: 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.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.A supplier manufacturing defect was confirmed.Design, ifu, and labeling defects were not confirmed.Trend is in control.Fmea line item is appropriate.Root cause is being investigated in a capa.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8740449
• MDR Text Key: 149631227
• Report Number: 3008500478-2019-00145
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1