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

Model Number 104-4470

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that, after the microblloon was inflated four times, in the fifth inflation a rapid emptying of the balloon was observed and it was impossible to re-inflate the balloon.Additional information received confirmed that the balloon had burst during use.The patient was undergoing surgery for left internal carotid aneurysm embolization in the posterior communicant.There was not extensive guidewire manipulation, with the guidewire used noted as the.010" wire which comes with the balloon.During inflation the guidewire tip advanced out 50mm from the catheter tip, with the tip shaped in a "c" form by the physician.A 1:1 contrast medium and.9% saline solution were used, with a 3ml syringe and slow inflation/deflation maneuvers used.The injection rate for this was slow.To deflate the balloon a 3ml syringe was expirated.It was noted that the issue was probably being characterized by balloon drilling.There was no withdrawal of the microguage at any time nor any return of blood obstructing the balloon.The balloon and guidewire was flushed as indicated per the ifu.There were no patient symptoms alleged.The balloon and guidewire were not inspected post removal, nor was contrast observed leaking during the inflation attempt.

Manufacturer Narrative

Device available, return date - additional information date manufacturer received - additional information type of report - additional information follow-up type - additional information device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the hyperform occlusion balloon catheter and guidewire were returned for analysis.The guidewire distal tip was found to be bent.It was reported the guidewire tip was shaped by the physician.What appears to be dried contrast was found with in the hyperform occlusion balloon catheter hub.An unsuccessful attempt was made to flush the hyperform occlusion balloon catheter as it was found to be occluded with what is likely dried contrast.In order to test for balloon inflation, the catheter body was separated (cut) and a mandrel into the distal tip of the balloon.An attempt was made to inflate the balloon; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker band.Upon microscopic examination, a defect (hole) in the chronoprene tubing was found at the location of the leak.No ¿ruptures¿ were found with the balloon.Based on the device analysis and reported information, the customer¿s report of ¿no/slow inflation during procedure¿ was confirmed.It is likely the multiple inflations of the balloon during use contributed to the event.However, the root cause for the damage could not be determined.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8047078
• MDR Text Key: 128257893
• Report Number: 2029214-2018-00924
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K011656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

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: 07/13/2019
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: A406565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 78