MAUDE Adverse Event Report: EV3 NEUROVASCULAR HYPERFORM OCCLUSION BALLOON SYSTEM; OCCLUSION SYSTEM, PRODUCT CODE: MJN

Model Number 104-4470

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

The pt presented with a tumor growing in the carotid artery.On (b)(6) 2014, the pt underwent a surgical resection.During the procedure, the carotid artery was damaged and the vessel was packed.It was decided to occlude the carotid artery for endovascular intervention using a hyperform balloon for proximal control while occluding the damaged vessel with coils.The balloon was prepared per the ifu (instructions for use) and then inflated inside the pt.The inflated balloon was reported to be undersized compared to the vessel and not maintaining inflation as there was a leak at the tuohy adaptor around the guidewire.An attempt was made to inflate the balloon even; however, burst upon further inflation.The balloon was removed from the pt.A second balloon was used and the same issue occurred.A third balloon was used and the procedure was successfully completed as planned.The pt was reported to be fair as original neurological issues were present.Same event as mdr# 2029214-2014-00514.

Manufacturer Narrative

The balloon catheter was returned for eval without the guidewire and a hole was found distal of the distal marker band; however the cause could not be determined.All balloons are 100% leak tested and 100% inspected for damages and irregularities during manufacture.(b)(4).

• Brand Name: HYPERFORM OCCLUSION BALLOON SYSTEM
• Type of Device: OCCLUSION SYSTEM, PRODUCT CODE: MJN
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4095061
• MDR Text Key: 4834485
• Report Number: 2029214-2014-00515
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2014

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: Other
• Device Expiration Date: 04/22/2015
• Device Model Number: 104-4470
• Device Lot Number: 9736494
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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