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

Model Number ICF100

Device Problems Inflation Problem (1310); Appropriate Term/Code Not Available (3191)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Loss of balloon pressure.The reported event could not be confirmed since the subject device was not returned for evaluation.The root cause of this event remains indeterminable.

Event Description

It was reported that during a minimally invasive mitral valve repair procedure the balloon of an icf100 intraclude device lost volume several times resulting in loss of occlusion.Trouble shooting was performed and no adverse events occurred as a result of this issue.As reported, no abnormality was noticed during preparation.Initial balloon pressure was 395 mmhg.Occlusion was lost at 360 mmhg.Pressure loss occurred during bypass, following arrest.Initial volume added was 35cc; 1 cc was added to occlude seven times throughout the case.When there was loss of balloon pressure, aorta pressure was 12 mmhg roughly.No blood was seen in the surgical field.There was a rise in aortic root pressure when balloon pressure dropped.No aspirated bloody return was there during balloon deflation.No leak was noted after removal from the patient.The same device was used to finish the case.

Manufacturer Narrative

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.Per the engineering evaluation, no defect was noted prior to use, a clinical failure could not be confirmed.The device was not returned for evaluation.A definitive root cause could not be determined at this time.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: 7567084
• MDR Text Key: 110048232
• Report Number: 3008500478-2018-00070
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

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: 02/05/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61259627
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 07/23/2020
• Supplement Dates FDA Received: 07/09/2018; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR