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

Model Number ICF100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation.Evaluation is in progress.Once additional information is available, a supplemental mdr will be submitted.

Event Description

It was reported that an icf100 balloon was thought to have "elongated" during the procedure.The patient had a 30mm dacron graft in his aorta, which the balloon was seated into.About an hour into the case (initial inflation, cross clamping and cardioplegia delivery was uneventful) the balloon pressure went from 380mmhg to 260mmhg.First occurrence was during the suture placement for the mvr.Additional volume was added to the balloon (not certain how much as this is a very experienced surgeon with this product) twice to compensate for the lower pressure.Total volume added was estimated to be 5-10cc.The balloon lost occlusion after each pressure drop.They discontinued using the balloon as they finished the case (fibrillating heart, cooled the patient).Patient came off bypass well and without issue.It is unknown if the balloon was tested after removal, however since the total volume was not there upon removal, it is assumed it leaked into the patient.Introducer model was er23b.The patient had a previous avr with root sparing aneurysm repair along with mv repair approximately one year and five months ago by another surgeon at another institution.The distance between the aortic valve and the innominate is unknown.Manufacturer and part number of the graft is unknown.

Manufacturer Narrative

H3.Device evaluation: customer complaint of abnormal balloon shape was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the cannula balloon was inflated and a balloon aneurysm was observed.Balloon inflated but failed to maintain inflation due to a pin hole leakage.All other through lumens were found to be patent without any leakage or occlusion.Customer reports of decreased balloon pressure reading and occlusion difficulty were unable to be confirmed.Balloon appeared to have surface indentations.No other visual damage or other abnormalities were found.Photos attached by complaint handler appeared consistent with lab findings.H10.Additional manufacturer narrative: updated h3.Udi (b)(4).

Manufacturer Narrative

H10: additional manufacturer narrative: updated section h6.Root cause cannot be determined at this time.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated sections d4 (expiration date) and h4.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Brand Name: INTRACLUDE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11025337
• MDR Text Key: 222013672
• Report Number: 3008500478-2020-00216
• 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,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 63398725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention