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

Model Number 105-5056

Device Problem Burst Container or Vessel (1074)

Patient Problems Ischemia (1942); Paresis (1998); Dysphasia (2195); Foreign Body In Patient (2687)

Event Date 04/28/2023

Event Type  Injury  

Event Description

Medtronic received a report that the distal part of the marathon catheter ruptured during the procedure. due to the rupture of the microcatheter, there was an outflow of onyx embolic fluid in healthy vascular territory.The patient presented an ischemic event, with aphasia and paresis of the extremities.The patient was in the process of rehabilitation, and the injury was said to be temporary.It was reported that the patient was hospitalized as a result of the event.There was no friction of difficulty during delivery.Aside from the rupture, there was no other damage to the catheter. the devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an arteriovenous malformation (avm). the patient's vessel tortuosity was moderate.The access vessel was 2.5mm in diameter.Ancillary devices include a chaperon guide catheter.

Manufacturer Narrative

E1.Street 1 (cont.): av 38 dg 59 50 clinica del norte 5 p 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 reported it was the first injection of the embolic fluid.It was a continuous injection, the injection is stopped immediately when embolic fluid is observed in territory where it was not the distal end of the microcatheter (microcatheter damage).A suggested injection was performed in the ifu of the company, not of any competitor.

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.

Manufacturer Narrative

Product analysis: as found condition: the marathon micro catheter was returned for analysis within a shipping box; within three various plastic biohazard pouches and within a dispenser coil.Visual inspection/damage location details: no damages or irregularities were found with the marathon micro catheter hub.A small amount of solidified onyx was found within the marathon catheter hub.The catheter body was found with a pinhole ruptured at 21.0cm from the distal end.No damages or irregularities were found with the distal tip or marker band.A small amount of solidified onyx was found within the distal tip.Testing/analysis: the marathon micro catheter total length was measured to be 173.1cm, the usable length was measured to be 166.9cm, which is within specification (specification: total (ref): 170.0cm; usable ~165.0cm ± 2.5cm).The micro catheter was flushed, and water exited the distal end as well as out of the ruptured location.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter rupture with onyx¿ report was confirmed.The rupture appears to have occurred as a result of over-pressurization.Rupture can occur during injection of embolic material or when the distal portion of the catheter is kinked, prolapsed, or occluded.Rupture can also occur due to high injection rate, use of palm of hand pressure, increased injection force against resistance, or pauses longer than two minutes.Customer reported no friction difficulty during delivery, devices were prepared per ifu, vessel tortuosity as moderate, and continuous injection was used.The catheter was not found fully occluded with onyx, therefore, the root cause for the rupture could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.The results of the catheter burst testing was reviewed for any anomalies; the data was within the expected and established specifications.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: MARATHON
• 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: 16868066
• MDR Text Key: 314549919
• Report Number: 2029214-2023-00739
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 06/30/2023

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 Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B315811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/12/2023; 06/16/2023
• Supplement Dates FDA Received: 05/15/2023; 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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 Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 70 KG