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

Model Number 105-5056

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Vasoconstriction (2126)

Event Date 11/10/2022

Event Type  Injury  

Event Description

Medtronic received a report that the operator flushed all the accessory devices as per ifu.The operator reached the fistula site of the mma very well with the micro wire but after that due to severe tortuosity of feeder artery, the marathon could not enter in.The operator tried 3-4 attempts to negotiate but no use.They took the envoy a little up tried to negotiate, but in that the middle meningeal artery (mma) had gone into spasm due to so much maneuvering of the marathon and hybrid wire.The marathon got kinked at the distal segment.Operator has stopped procedure <(>&<)> withdrew the marathon from the system.A sonic1.25 was used and the case was finished.The reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing arteriovenous malformation (avm) embolization.It was noted the patient's vessel tortuosity was severe.T he access vessel was the right middle meningeal artery (mma) branch with diameter of 1.7 mm.  ancillary devices include an envoy 5f guide catheter, hybrid 0.07 guidewire and squid 12 liquid embolic.

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 received clarified that due to tortuosity the marathon was not able to cross.The patient did not experience any symptoms, and was recovering from the procedure normally.The patient was given nimodipine intra arterial through the marathon to treat the mma spasm.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): the marathon micro catheter was returned for analysis within a shipping box; within an opened marathon micro catheter outer carton and within an opened marathon micro catheter inner pouch.The balt hybrid guidewire used during the event was not returned.Visual inspection/damage location details: the balt hybrid guidewire has an od (outer diameter) of 0.007¿, as per an online source.Per the marathon micro catheter ifu (instruction for use) the marathon micro catheter is not compatible with guidewires greater than 0.010¿ in diameter.Therefore, the balt hybrid guidewire was found to be compatible for use with the marathon micro catheter.The marathon total length was measured to be ~(b)(4) (reference (b)(4)), the usable length was measured to be ~138.2cm which is not within specification.The distal floppy length was unable to be measured as the distal end was found to be separated and not returned.No damages were found with the marathon hub.The catheter body was found to be accordioned beneath strain relief for ~7.0cm.No other anomalies were observed.Testing/analysis (including sem reports): n/a.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was unable to be confirmed and the root cause could not be determined.It is possible that the patient vessel tortuosity contributed to the resistance.In this event, user error may have contributed to the reported issue as the physician continued to advance despite resistance.Per the marathon ifu (instructions for use): ¿the marathon is a flow directed micro catheter that can optionally be used with hydrophilic, 0.010" or less sized guidewires.The marathon is not compatible with non-hydrophilically coated guidewires greater than 0.010" in diameter.Never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy.Excessive force against resistance may result in damage to the device or vessel perforation.¿ based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damage¿ was confirmed as the returned marksman catheter was found to be separated at distal end.However, the event cause could not be determined.Possible causes for ¿catheter kink/damage¿ are customer damaged catheter during removal from packaging or incompatible guidewire or delivery system.The customer reported vessel tortuosity as severe.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: 15794465
• MDR Text Key: 303632381
• Report Number: 2029214-2022-01932
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: A993150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 58 KG