MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERGLIDE 4.0 X 20 MM 4 MM TIP; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4127

Device Problem Burst Container or Vessel (1074)

Patient Problems Paresis (1998); No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, the device analysis has yet not began.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the hyperglide balloon burst during a procedure.Prior to the event, the patient had just undergone a mechanical thrombectomy procedure and a middle cerebral artery (mca) stenosis was noticed upon removal of the clot.The physician wanted to angioplasty the stenosis before placing the stent.During the angioplasty, the hyperglide balloon was inflated in a vessel that was 1.7mm distal and 2.5mm proximal to its nominal size and that was when the reported event occurred with the balloon.The balloon was, subsequently, removed from the vessel with difficulty.Upon removal from the body, the balloon was broken by the scrub technician to ensure that the wire had not broken.The balloon was tested prior to use, and it performed as intended during testing.10-15mm the guidewire tip was advanced out of the catheter tip during the inflation.The contrast ratio was 50/50.Only one time the balloon get inflated and deflated.The injection rate was steady.Non cadence, regular 1ml syringe was used.The patient vessel was normal.

Event Description

Post the intervention and the reported event, the patient was reported to have slightly weaker in the right hand.

Manufacturer Narrative

Event description - additional information codes updated 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

H3: the hyperglide occlusion balloon catheter was returned separated into two segments.It was reported that upon removal from the patient, the balloon was broken by the scrub technician.The hyperglide occlusion balloon catheter proximal segment total length was measured to be ~158.0cm and the useable length was measured to be ~151.7cm.The hyperglide occlusion balloon catheter distal segment total length was measured to be ~17.2cm.No damages or irregularities were found with the hyperglide hub.The hyperglide catheter body was found stretched at ~151.0cm from proximal end of hub with the distal ~8.0cm of the hyperglide catheter body stretched.Approximately 3.5cm of a broken guidewire segment was found bent and stuck within the hyperglide catheter distal broken segment.Blood reflux was present within the balloon.The hyperglide balloon was found ruptured distal to distal marker band at what appears to be the distal bond.Due to its damaged condition the hyperglide balloon could not be used for inflation testing.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿balloon rupture during procedure¿ was confirmed; however, the root cause could not be determined.In this event, use context (off label use) likely contributed to the event as the hyperglide occlusion balloon catheter is contraindicated for angioplasty procedures.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.The use of a non-cadence syringe can also contribute to balloon over-inflation.The rate of inflation was ¿steady¿.However, information regarding balloon inflation volume was not reported.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: HYPERGLIDE 4.0 X 20 MM 4 MM TIP
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8612780
• MDR Text Key: 145521511
• Report Number: 2029214-2019-00464
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00847536005020
• UDI-Public: 00847536005020
• Combination Product (y/n): N
• PMA/PMN Number: K021066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Model Number: 104-4127
• Device Catalogue Number: 104-4127
• Device Lot Number: A406562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 04/26/2019; 07/17/2019
• Supplement Dates FDA Received: 06/14/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 136