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

Model Number ICF100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the intraclude balloon is not totally occlusive 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.The device has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once completed.

Event Description

Edwards received notification that issues were experienced during the use of an intraclude device model icf100.Indication for surgery was minimal invasive tricuspid valve repair (tvr).During prepping, they only checked that there was no leak at the balloon (they do not check the catheter as per routine).The initial balloon inflation pressure was 300 mmhg.The balloon pressure started falling, the aortic root pressure started rising and the heart started beating.Once the balloon dropped below 250 mmhg, they added extra volume.The 54 ml were added over the duration of the procedure, approximately 2 ml added every 5 minutes.The balloon was deflated once the tvr was completed but before atrium closure because it was not effective so they changed to beating heart surgery.Additional cardioplegia had to be provided.After the tvr, the balloon had to be re-inflated because the valve needed replacing.Again they experienced the same issue while using the intraclude.There was blood in the fluid aspirated from the balloon on deflation and once the balloon was removed, there was visible blood inside the balloon.The patient was hospitalized in stable condition.The balloon was tested after use and the surgical team (very experienced with the intraclude device) found a leak on the catheter where the sizing increases from small diameter at the balloon end to bigger diameter further along the catheter.There was a noticeable seam and fluid identified dripping from this point.The device was cleaned using haz-tabs cleaning solution and was returned for evaluation.

Manufacturer Narrative

Evaluation summary: customer complaint of leakage from mid-shaft area was confirmed.As received, the catheter shaft was found kinked near the balloon.The device started leaking at the mid-shaft connection area when inflating the balloon inflation lumen with water.All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.The ifu instructs users to, "visually examine the intraclude device and sterile packaging for evidence of damage (e.G.Rips, tears, etc.).If damaged, do not use".Additional instructions are provided on how to handle the device properly during preparation, insertion, inflation, and removal.Instructions on how to manage leaks and loss of occlusion are also in the ifu.Per the product evaluation and the engineering evaluation, a supplier defect was confirmed.An edwards manufacturing, design, ifu, and labeling defect was not confirmed.The trend was reviewed and was found to be out of control.Corrective action was initiated.

Manufacturer Narrative

Corrected data: f10, h6.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: 7584600
• MDR Text Key: 110573185
• Report Number: 3008500478-2018-00071
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 07/23/2020
• Supplement Dates FDA Received: 07/19/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR