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

Model Number 105-5091-150

Device Problems Collapse (1099); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 12/26/2023

Event Type  malfunction  

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

Medtronic received that an echelon catheter had resistance and was damaged.The patient suffered from an aneurysm of the anterior co mmunicating segment of the internal carotid artery.When the surgeon was preparing for shaping, after many attempts, the shaping needle could not enter the tip end of the 105-5091-150 microcatheter.When taken out, it was found that the tip end was ruptured.After replacing it with a new 105-5091-150 microcatheter, which was shaped smoothly.The surgeon stated that the 105-5091-150 microcatheter had product quality issues and there would be no charge for the reported product.The catheter was crushed in the distal section.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per ifu.The patient was being treated for an aneurysm.Vessel tortuosity was normal.The access vessel was the femoral artery with a diameter of 10mm.No patient injury or symptoms were reported.

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.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 reported there was a whole in the catheter.It was not punctured.

Manufacturer Narrative

Product analysis: as found condition: the echelon-10 catheter was returned for analysis within a shipping box, within an unsealed plastic biohazard pouch and within a dispenser coil.The shaping mandrel used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub.The echelon-10 was found kinked at ~9.2cm from the proximal end.The distal ~2.0cm of the micro catheter was found bent/wavy.The distal tip and distal marker band were found damaged/crushed.A pinhole was found proximal to the marker band.A small amount of dried blood was found throughout the micro catheter.Testing/analysis: the total length was measured to be ~156.6cm, and the usable length was measured to be ~147.8cm which is within specification (specification: total (ref) = 155cm, usable: 147cm ±1.5cm).The echelon-10 micro catheter was flushed, and water did not exit the distal end as it was occluded by the dried blood.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture (gw/stylet)¿ was confirmed as there was a pinhole puncture found near the distal tip.It is possible the puncture occurred during the tip shaping/preparation.The customer report of ¿catheter resistance¿ during tip shaping was confirmed.It is likely the cause of the resistance was the crushed micro catheter tip/marker found.It is possible the tip became damaged due to handling or during shaping attempt.Dried blood was found to have occluded the micro catheter.As the customer reported device was found damaged during preparation and not used, the cause of the blood occlusion 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.

• 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: 18433224
• MDR Text Key: 331776422
• Report Number: 2029214-2024-00011
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

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 Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B432139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/04/2024; 02/28/2024
• Supplement Dates FDA Received: 01/29/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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 Age: 66 YR
• Patient Sex: Female