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

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that hyperfrom balloon ruptured during the preparation.

Manufacturer Narrative

The hyperform occlusion balloon catheter and guidewire were returned.The hyperform balloon and guidewire were decontaminated.Dried residue, which is likely contrast, was found within the hyperform hub.No damages were found with the hyperform hub.No bends or kinks were found with the hyperform catheter body.Upon visual inspection, no damages were found with the hyperform balloon distal tip.Dried blood was found with the balloon sub-assembly and inflation holes.The hyperform occlusion balloon catheter was flushed, water and blood exited the distal tip.An in-house mandrel was inserted into the hyperform balloon distal tip.An attempt was made to inflate the hyperform balloon; however, the balloon could not maintain inflation as it was found leaking distal to the distal marker.Upon microscopic inspection, a defect in the balloon chronoprene tubing was observed at the distal tip.The guidewire was examined.No bends or kinks were found with the pushwire.The guidewire proximal and distal solder regions were found to be in good condition.The guidewire distal tip was found bent.The characteristics of the bent guidewire tip is consistent with tip shaping.However, it was reported the guidewire tip was not shaped.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿balloon rupture during set up¿ could not be confirmed.Evidence found with the returned hyperform occlusion balloon catheter, as blood was found with the returned device.This indicates that the device was used and is unlikely the event occurred prior to use or during the preparation.No ¿ruptures¿ were found with the balloon; however, the balloon was found torn causing the balloon to leak.The cause for the damage could not be determined as there is insufficient information.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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 BALLOON
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9511746
• MDR Text Key: 209012044
• Report Number: 2029214-2019-01291
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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: 03/20/2021
• Device Model Number: 104-4770
• Device Lot Number: A809888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1