MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5091-150

Device Problems Device Damaged by Another Device (2915); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

Event Description

Medtronic received information that an echelon catheter ruptured intact in the distal section by an avigo guidewire.For catheterization of the aneurysm, during the positioning of the microcatheter in the internal carotid artery (ica) with the avigo microguide, the physician observed that the tip of the straight echelon microcatheter was making a curve, in an attempt to catheterize the aneurysm the devices migrated to the middle cerebral artery, when the system was removed it was noticed that the avigo microguide was externalizing on the side of the tip of the microcatheter, not leaving through the primary lumem of the same.There was no friction or difficulty during delivery.There was no other damage to the catheter.The devices were prepared according to the instructions for use (ifu).The patient was undergoing a right carotid t aneurysm embolization.Vessel tortuosity was moderate.The access vessek was the right femoral with a diameter of 8mm.No patient symptoms or complications were reported.  ancillary devices: balast 6fx90 sheath, navien 072x115 - medtronic guide catheter.

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.

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 was received that the tip of the guidewire was not shaped.There was no damage found on the guidewire.

Event Description

Additional information received reported the tip of the guidewire was not shaped.There was no damage noted on the guidewire.

Manufacturer Narrative

B5 updated with additional information received.Associated with mdr #: 2029214-2023-02414 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: product analysis #706090608:equipment used: video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs105-5091-150 rev.Ba as found condition: the echelon-10 catheter was returned for analysis within a shipping box, within a resealable plastic biohazard pouch; within an opened echelon-10 outer carton and within a second resealable plastic pouch.The avigo guidewire used during the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub.The proximal marker band, distal marker band and distal tip were found crushed.A rupture or puncture was found proximal to the distal marker band.Testing/analysis: the total length was measured to be ~156.2cm, and the usable length was measured to be ~148.4cm which is within specification (specification: total (ref) = 155cm, usable: 147cm ±1.5cm).The echelon-10 micro catheter was flushed, and water was found to exit the distal end as well as the ruptured location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture (gw/stylet)¿ was confirmed.It is possible the puncture occurred during preparation when the guidewire was inserted into the micro catheter prior to insertion into the navient and body.Customer reported finding the puncture after removal from the body, no friction/difficulty during procedure, and devices were prepared per ifu.The likely cause could not be determined.The customer report of ¿catheter kickback¿ typically cannot be confirmed through device analysis.It is possible the catheter kickback occurred due to the catheter puncture.Other possible causes include catheter tip under stress, or patient vessel tortuosity.Customer reported vessel tortuosity as moderate.Therefore, the likely cause could not be determined.As the avigo guidewire used in the event was not returned, any contribution of the avigo towards the catheter puncture and catheter kickback could not be assessed.The avigo guidewire is compatible for use with the echelon-10 micro catheter.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: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18361266
• MDR Text Key: 331190644
• Report Number: 2029214-2023-02413
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B496172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female