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

Model Number 105-5056

Device Problems Burst Container or Vessel (1074); Collapse (1099)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that there was a catheter rupture with onyx the patient was undergoing surgery for mav treatment.The vessel tortuosity was minimal.The access vessel was 6 fr with a diameter of 4mm.It was reported that it entered with the microcatheter and when they performed a contrast injection they did not see an image, the contrast did not come out through the tip of the microcatheter.It was removed and observed outside the patient that only drops of contrast came out.The tip of the microcatheter was perceived as crushed in the distal section.There was a catheter rupture (intact) with onyx in the distal section.There was no friction or difficulty during delivery.The injection rate was 1 vial.  the reported device and any accessory devices were prepared as indicated in the ifu.The catheter flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.No medical/surgical intervention was needed to prevent a permanent impairment of a function.The event did not lead to or extend hospitalization.  ancillary devices include a mirage guidewire.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): the marathon micro catheter was returned for analysis within a shipping box; within a plastic bag and within an opened marathon micro catheter inner pouch.Visual inspection/damage location details: the marathon total length was measured to be ~171.1cm (reference 170.0cm), the usable length was measured to be ~164.9cm which is within specification (specification 165.0cm ± 2.5cm) and the distal floppy length was measured to be ~26.0cm which is within specification (25.0cm +2.0cm -1.0cm).No damages were found with the marathon hub.No bends or kinks were found with the catheter body.The distal tip did not exhibit necking or stretching.There appeared to be a distal tip separation at proximal end of marker band and not a rupture.No onyx residue was found within the marathon hub, or distal tip.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter rupture¿ was unable to be confirmed.However, a separation at marker band was found on catheter distal tip.Possible causes for catheter rupture are due to over-pressurization, resulting in pressures exceeding the limits of the micro catheter, pauses longer than two minutes prior to re-injection can cause solidification of onyx les at the catheter tip resulting in catheter occlusion, and use of excessive pressure to clear the catheter, may result in catheter rupture.Rupture can also occur during injection of embolic material or when the distal portion of the catheter is kinked, prolapsed, or occluded; injection rate; use of palm of hand pressure or increased injection force against resistance.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: 12668196
• MDR Text Key: 278110208
• Report Number: 2029214-2021-01318
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: 12/07/2023
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B128483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG