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 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a marathon catheter that ruptured during an onyx procedure and onyx flowed into the guide c atheter.It was reported that a patient underwent a procedure to treat an arteriovenous fistula with onyx liquid embolization.One vial of on yx-18 was injected and implanted to plan and the procedure was going normally until angiographic images.Several minutes had passed without injecting onyx but the physician wanted to administer more onyx.Another vial of onyx-18 (lot: b026614) was then administered.During the injection, resistance was noted at the distal end of the catheter and it was observed that the onyx was exiting approximately 10cm from the marathon catheter tip into the guide catheter.It was noted that all devices were prepared and the catheter was flushed according to the instructions for use (ifu).There was no friction or other difficulty observed during delivery of the catheter.There was no other damage to the catheter besides the rupture.There was no injury to the patient.

Event Description

Additional information received reported all the onyx that came out due to the rupture of the microcatheter remained inside the guide catheter.The procedure was completed without any inconvenience or complications to the patient.

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

H3.Product analysis findings: the marathon micro catheter was returned within the inner pouch; inside of the biohazard bag and a shipping box.The onyx was not returned as it was consumed in the patient.The marathon total length was measured to be 171.0cm, the usable length was measured to be 165.0m which is within specification and the distal floppy length was measured to be 25.5cm which is within specification.Onyx residue was found within the marathon hub.Catheter body was found to be kinked at 5.5cm from the distal tip.No damages were found with the marathon distal marker/tip.The marathon distal tip and lumen was found to be occluded with solidified onyx residue.The entire surface of the marathon catheter body was examined under magnification.The marathon catheter body was found to be ruptured at 6.0cm from the distal tip.The marathon micro catheter was pressurized with water and found non-patent as it was found to be occluded with the onyx.Based on the device analysis and reported information, the customer¿s report of ¿catheter rupture¿ was confirmed as the returned marathon was found ruptured.In addition, the catheter body was also found to be kinked.The rupture appears to have occurred as a result of over-pressurization.Rupture can occur during injection of embolic material or when the distal portion of the catheter is kinked, prolapsed, or occluded.Rupture can also occur due to high injection rate, use of palm of hand pressure, increased injection force against resistance or pauses longer than two minutes.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.The results of the catheter burst testing was reviewed for any anomalies; the data was within the expected and established specifications.There was no non-conformance to specifications identified that led to the reported issue.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
• MDR Report Key: 11544176
• MDR Text Key: 241937582
• Report Number: 2029214-2021-00319
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• 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,Followup
• Report Date: 06/28/2021

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 Expiration Date: 09/24/2023
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B093648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 03/21/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 03/23/2021; 06/11/2021
• Supplement Dates FDA Received: 04/09/2021; 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65