MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR HYPERFORM LINE EXTENSION; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4370

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

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

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

The hyperform occlusion balloon catheter was returned for analysis.The hyperform guidewire was not returned as it was discarded.Upon visual inspection, no issues or irregularities were found with the hyperform hub.No bends or kinks were found with the hyperform catheter body.An attempt was made to flush the catheter lumen with water; however, was found to be occluded with what is likely to be dried contrast.In order to test for balloon inflation, the balloon subassembly was separated (cut) from the catheter body.A mandrel was inserted into the distal tip of the balloon for leak test.An attempt was made to inflate the balloon; however, the balloon was found to be leaking.Upon microscopic examination, the balloon was found to be ruptured at the leak.Based on the device analysis and reported information, the report of ¿no/slow inflation during set up¿ was confirmed.The appearance of the balloon is consistent with failure due to over-inflation.Rupture can occur when the balloon is inflated beyond the rated volume or due to inflation rate.However, the cause for the balloon rupture could not be conclusively determined.A device history record review did not identify any anomalies associated with this event.These types of events will be monitored as part of post market vigilance complaint trending and monitoring.Per instructions for use (ifu), ¿to inflate the balloon, use the 1 cc syringe to gently infuse the desired volume of recommended contrast solution.Balloon cannot inflate unless a portion of the distal 10 cm of the guidewire tip is occluding the distal inflation holes of the catheter.Do not exceed the maximum recommended inflation volume as balloon rupture may occur".If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of hyperform balloon non-inflation.It was reported that when performing the balloon inflation test, the balloon did not inflate.The balloon was observed to be leaking.There was reportedly no damage observed.The balloon is not used and was exchanged for another.

• Brand Name: HYPERFORM LINE EXTENSION
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8348963
• MDR Text Key: 139242833
• Report Number: 2029214-2019-00125
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K101570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2019

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: 12/04/2020
• Device Model Number: 104-4370
• Device Lot Number: A649314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1