MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM; 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 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

The hyperform balloon has not been returned for evaluation; therefore, 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 a report that while inflating the air for a test, balloon was exploded.There were not any patient symptoms or complications associated with this event.Device was not used in the procedure.No patient injury was reported.

Manufacturer Narrative

H3: the hyperform occlusion balloon catheter and guidewire (model: 104-4770 lot: a809888) were returned for analysis.The guidewire was found protruding from within the catheter hub for ~119.0cm.Upon visual inspection, no damages were found with the hyperform hub, body or distal tip.The guidewire was removed from within the catheter lumen with slight resistance.Upon visual inspection, what appears to be dried contrast was found on the guidewire proximal solder region.No issues or irregularities were found with the guidewire distal solder region.The guidewire distal tip was found to be bent.The bend is consistent with shaping; however, it was not known if the guidewire tip was shaped during use.The guidewire distal tip od (outer diameter) was measured to be 0.0099¿ which is within specification (specification: 0.0103¿ max).An attempt was made to flush the hyperform occlusion balloon catheter but was found occluded with what is likely dried contrast.In order to test the balloon for inflation, the catheter body was separated (cut) a nd a mandrel was inserted into the distal tip.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 at the tip.Upon microscopic 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.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review will be performed.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ could not be confirmed as the balloon was not found to be ruptured.However, the device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.It is likely the damage to the balloon contributed to the event.Over-inflation of the balloon can cause the balloon to become damaged.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

Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated the guidewire was discarded.The guidewire tip advanced to the very distal end of the catheter tip during inflation.The xpedion10 wire was used with the balloon for the inflation test.The procedure type was a bto.A competitor's product was used to complete the procedure and the distributor currently had the device for return.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10180895
• MDR Text Key: 196944591
• Report Number: 2029214-2020-00577
• 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: 09/24/2020

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 Catalogue Number: 104-4770
• Device Lot Number: A809888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 09/02/2020
• Supplement Dates FDA Received: 07/05/2020; 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 75