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

Model Number 105-5056

Device Problems Burst Container or Vessel (1074); Compatibility Problem (2960)

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

Event Date 08/30/2022

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 a report that a marathon and apollo catheters were occluded which prevented onyx from passing normally.After the catheters were replaced the procedure went smoothly, and it was stated that the issue was with the catheters.There was resistance with the onyx injection in the distal part of the marathon catheter. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an aneurysm malformation.The patient's vessel tortuosity was normal.The access vessel was the femoral artery, which was 8mm in diameter.Additional information received reported that the dead space of the delivery catheter was filled with dmso.A continuous injection was used, and there was no wait time as the problem was found when injected the first tube of onyx.The distal part of the catheter was blocked and had a hole.

Manufacturer Narrative

H3: product analysis #705192005:equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs105-5056 rev.H as found condition: the marathon micro catheter was returned for analysis within a shipping box, within a sealed plastic biohazard pouch; within an opened marathon inner pouch; and within a dispenser coil.An apollo micro catheter was also returned and will be addressed in pli-20 visual inspection/damage location details: the entire surface of the marathon micro catheter was examined under magnification; no pinholes or ruptures were found.Onyx residue was found within the marathon hub.No damages were found with the marathon hub, catheter body or distal tip.Testing/analysis: the marathon total length was measured to be ~173.5cm, the usable length was measured to be ~167.3cm which is within specification (specification: total (ref) = 170cm, usable = 165.0cm ± 2.5cm).The micro catheter was flushed, and water did not exit the distal end as it was found occluded.An in-house 0.010¿ mandrel was inserted into the marathon micro catheter and became stuck within the hub when inserted proximally and at the distal tip when inserted distally.The catheter was cut, and onyx was found within the catheter.The inner diameter of the marathon catheter cannot be measured due to the occlusion.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter rupture¿ could not be confirm.The customer¿s report of ¿catheter occlusion¿ was confirmed.It is possible the onyx became exposed to water, saline or blood causing the onyx to solidify and caused the occlusion.This can occur in the hub, catheter lumen, or the needle used to draw the onyx from the vial.Customer reported dead space was filled with dmso, continuous injection was used, and no wait time before injection.Therefore, the cause could not be determined.There is no evidence suggesting that the marathon micro catheter was defective.Ngod10 2022-10-21 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 that the catheter had a hole.The rupture was suspected to be at the transition section of the distal soft section.A hole was found during the injection process, and no other unconventional operations were performed.

• 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: 15492557
• MDR Text Key: 300861945
• Report Number: 2029214-2022-01629
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• 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
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B270535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male