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

Model Number 105-5056

Device Problems Break (1069); Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

Unknown healthcare professional information unavailable due to privacy laws.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.

Event Description

Medtronic received a report that the marathon catheter trapped onyx causing the catheter to rupture.The patient was undergoing surgery for a cerebral arteriovenous malformation.The accessed vessel was the mca with a diameter of 2 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that the patient received treatment for avm from mca, and at the last minute, marathon trapped onyx, which could not be removed and ruptured.It remained from the ic to m1.The patient then underwent an emergency operation.The surgeon was able to remove it, but the part that was trapped in onyx could not be removed, so it remained in the body.No patient complications or other problems occurred.It was reported catheter rupture occurred.The product box was no damaged.There were no traces of the product being opened prior to use.There was no resistance during injection.The fracture location is the distal portion of the shaft of the catheter.There was no excessive load applied to the catheter during delivery or removal.There was adhesion or stuck to the catheter tip that occurred.There was no vasospasm.There was not something stuck inside the guiding catheter.The fragment separation is inside the patient's body in the mca in front of the nidus extraction site.There was no additional surgical or medical treatment performed.The device was prepared as per the instructions in the package insert.The catheter was flushed as indicated in the inst ructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a fubuki 6f guide catheter, guidepost 120 cm microcatheter, and tenrou 200 cm guidewire.

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 was received that the prognosis after avm removal was stable.It was noted that the waiting time between injection was it basically stops 30 seconds, but sometimes it was 15 seconds depending on the doctors sense.The physician paused if there was back flow.The dead space of the delivery catheter was filled with dsmo and there was no problem with it.The injection rate was followed as indicated in the ifu.The liquid embolic did not get embedded in an unintended location.

• 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: 16357494
• MDR Text Key: 309331246
• Report Number: 2029214-2023-00248
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: B384438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 02/22/2023
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Other
• Patient Sex: Male