MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM 4.0 X 7 MM SYS TEM; 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 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

The hyperform balloon was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device and/or additional information a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that hyperform balloon ruptured during preparation balloon assisted coiling treatment.The event happened prior to use in the patient.

Manufacturer Narrative

D10: device available for evaluation - additional information.G4.Date mfr rec ¿ additional information.H2: type of follow up - device evaluation.H3: device evaluated by manufacturer- additional information.H6: codes updated.The device was returned for evaluation and the clinical observation could not be confirmed as there was not any ruptured found on the balloon.There were not any damages found with the hyperform hub and catheter.No damages or irregularities were found with the balloon.An attempt was made to flush the hyperform occlusion balloon catheter; however, could not be flushed as it was likely occluded with dried contrast.In order to test for balloon inflation, the catheter body was separated (cut) and a mandrel was inserted into the distal tip of the hyperform 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.The device evaluation showed the balloon could not maintain inflation due to the defect (hole) in the chronoprene tubing.The balloon defect is not consistent with over-inflation (rupture) damage.However, the root cause for the damage could not be determined.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.

Manufacturer Narrative

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.

Event Description

50/50 contrast ratio was used, the balloon was inflated/deflated 1 time for preparation.As a result of the issue another balloon was used.There were no related patient symptoms.Ancillary devices include an x-pedion guidewire.

• Brand Name: HYPERFORM 4.0 X 7 MM SYS TEM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8799409
• MDR Text Key: 151337914
• Report Number: 2029214-2019-00753
• 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,Followup
• Report Date: 09/25/2019

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: 10/12/2021
• Device Model Number: 104-4470
• Device Catalogue Number: 104-4470
• Device Lot Number: A759166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 09/23/2019
• Supplement Dates FDA Received: 08/11/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1