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 Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

It was reported that an intra-arterial occlusion balloon leaked without rupture.Upon follow-up, it was reported that the leak was noted during cardioplegia delivery during a robotic mitral valve repair case.The balloon leak was identified by a low balloon pressure which measured 140mmhg, and the inability to completely arrest the heart.This occurred within minutes of balloon inflation.A second device was inserted within a couple of minutes and was used without issues.There was no evidence of balloon leak or damage during preparation, and no unique patient anatomy or calcification was noted.Upon removal of the first device, blood was observed within the balloon.There was no adverse patient outcome.

Manufacturer Narrative

Evaluation summary: the device was received for evaluation, and the reported condition of balloon leak was not confirmed.The catheter balloon inflated concentric and remained inflated without leakage; however, traces of blood were noted inside the balloon.All lumens were found to be patent without evidence of leakage or occlusion.No other visual damage, contamination, or other abnormalities were found during the assessment of the device.The device will be sent to the supplier for additional testing, and findings will be provided in a supplemental report.

Manufacturer Narrative

Evaluation summary: the supplier evaluation revealed a balloon leak at the distal end of the catheter shaft, at the location of the pressure lumen.The leakage identified was caused by a bent cardioplegia seal mandrel.Additional manufacturer narrative: a supplier manufacturing defect was confirmed.This has been addressed with the supplier through investigation and corrective action has been initiated.The device history record (dhr) was reviewed and showed that this device met all manufacturing specifications for product release prior to distribution.The ifu and training manuals were reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Trends will continue to be monitored through the use of edwards quality systems.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; m/s mle 8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5287687
• MDR Text Key: 33235882
• Report Number: 3008500478-2015-00075
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2015

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 Model Number: ICF100
• Device Lot Number: 60070807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2016; 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR