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

Model Number 105-5056

Device Problem Device Damaged by Another Device (2915)

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

Event Date 09/05/2022

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 the distal shaft of the marathon catheter was perforated by the guidewire.The patient was undergoing treatment for a onyx embolization of an arteriovenous malformation (avm).The patient's vessel tortuosity was moderate.The access vessel was the right middle cerebral artery, which was 2mm in diameter.It was reported that the feeder came out from the m1 protruding from the ic, and the tortuosity was slightly stronger, so it was shaped using a heat gun.When an attempt was made to deliver it with chikai10 guidewire, an abnormality was detected because the chikai appeared earlier than the marker. there was no resistance when passing the guidewire. the device was replaced, and the patient did not experience any health damage.The devices were prepared and flushed according to the instructions for use (ifu).

Event Description

Additional information received reported that the it was suspected that the event might have occurred due to heatgun shape.

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

Product analysis: ¿ as found condition: the marathon catheter was returned for analysis within a shipping box; within a plastic bio-pouch; and within an opened marathon outer carton and inner pouch.The (asahi) chikai-10 guidewire 0.010¿ guidewire used in the event was not returned.The (asahi) chikai-10 guidewire 0.010¿ guidewire has a labeled proximal od (outer diameter) of 0.010¿ and distal od of 0.010¿, as per an online source.Per the marathon ifu (instructions for use), the marathon is not compatible with non-hydrophilically coated guidewires greater than 0.010¿ in diameter.Therefore, the (asahi) chikai-10 guidewire 0.010¿ guidewire was found compatible for use with the marathon micro catheter.Visual inspection/damage location details: the marathon total, usable and distal floppy segment lengths were measured to be within specification.No damages or irregularities were found with the marathon hub.No bends or kinks were found with the marathon catheter body; however, the catheter body was found punctured at ~0.5cm from the distal tip.No damages or irregularities were found with the marathon distal marker/tip.No other anomalies were observed.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture¿ was confirmed.Catheter puncture can occur if the catheter becomes kinked or prolapsed during insertion of the guidewire.In addition, it is possible the patient¿s ¿moderate tortuous¿ anatomy contributed to the event.However, the cause for the puncture 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.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: 15474255
• MDR Text Key: 306409348
• Report Number: 2029214-2022-01611
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2022

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: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B380674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 10/31/2022
• Supplement Dates FDA Received: 10/27/2022; 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female