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

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

The hyperform balloon has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the occlusion balloon ruptured during preparation for a balloon assisted coiling procedure.No patient injury was reported as a result of the event.

Manufacturer Narrative

The hyperform occlusion balloon catheter (model: 104-4770 lot: a604486) was returned for analysis within a shipping box and within a plastic bio-pouch.The hyperform guidewire was not returned.The reason for the guidewire not returning was not provided.Upon visual inspection, no damages were found with the hyperform occlusion balloon catheter hub, body or distal tip/balloon.What appears to be dried blood was found within the balloon.An attempt was made to flush the hyperfrom occlusion balloon catheter 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.The balloon was then inflated by inserting a mandrel into the distal tip of the balloon for the leak test.An unsuccessful attempt was made to inflate the balloon as it was found to be leaking distal to the distal marker band.Upon examination, a defect (tear) in the balloon chronoprene tubing was found at the location of the leak.No balloon ¿ruptures¿ were found.No other anomalies were observed.The hyperform occlusion balloon catheter was returned for analysis without the guidewire.What appears to be dried blood was found within the balloon.An unsuccessful attempt was made to inflate the balloon as it was found to be leaking distal to the distal marker band.Upon examination, a defect (tear) in the balloon chronoprene tubing was found at the location of the leak.No balloon ¿ruptures¿ were found.Based on the device analysis and reported information, the customer¿s report of ¿balloon rupture during set up¿ could not be confirmed as the balloon was not found to be ruptured.The device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The balloon defect is not consistent with over-inflation (rupture) damage.In addition, dried blood was found within the balloon indicating that the device was likely used in the patient.As the balloon is to be tested prior to use in the patient, it is likely the damage occurred during the procedure.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: 8081090
• MDR Text Key: 127862449
• Report Number: 2029214-2018-00949
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K091458
• 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: 01/14/2019

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 Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A604486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 57