MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON 165 AVM CATHETER NO STYLET; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The catheter has been returned and analysis is pending.A follow-up mdr will be submitted when the investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of catheter entrapment during a procedure.The patient was undergoing thrombectomy treatment for meningioma preoperative embolization.The devices were prepared as indicated in the ifu.It was reported that a liquid embolic was injected from the maratho.Afterward, catheter entrapment occurred when attempting to remove the catheter.A guidewire was inserted and an attempt was made to remove the catheter.It was reported that the guidewire came out of a perforation in the tip of the marathon.The marathon was able to be removed.There were no reports of patient injury.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, marathon catheter returned with non-medtronic guidewire stuck inside the marathon catheter lumen.No bends or kinks were found with the marathon catheter body; however, the catheter body was found punctured at the distal tip.No damages or irregularities were found with the marathon distal marker/tip.The non-medtronic guidewire was found protruding from the catheter puncture location.An attempt was made to remove the guidewire from within the marathon catheter lumen; however, resistance was encountered, and the guidewire was found stuck.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿catheter entrapment/difficult removal¿ could not be confirmed.Difficult catheter removal/entrapment may be caused by angioarchitecture (very distal arteriovenous malformation fed by afferent, lengthened, small, or tortuous pedicles) or vasospasm.However, the cause for the reported entrapment could not be determined.Catheter puncture can occur if the catheter becomes kinked or prolapsed during insertion of the guidewire.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 165 AVM CATHETER NO STYLET
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9351922
• MDR Text Key: 195409389
• Report Number: 2029214-2019-01151
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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 Lot Number: A780365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1