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

Model Number 105-5056

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 12/28/2009

Event Type  malfunction  

Manufacturer Narrative

Associated with rr #: 2029214-2022-01221.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

Santillan, a., zink, w., knopman, j., riina, h., & gobin, y.P.(2009).Balloon-assisted technique for trapped microcatheter retrieval following onyx embolization.A case report.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences, 15(4), 453¿455.Https://doi.Org/10.1177/159101990901500414.Medtronic review of the literature article found: during embolization of a large frontal arteriovenous malformation (avm), onyx-18 was injected into an m3 branch of the middle cerebral artery via a marathon microcatheter.After 40 minutes of embolization, microcatheter retraction from the mca feeding artery was attempted without success, despite prolonged, robust attempts during which there was displacement of the onyx cast.A hyperform balloon microcatheter was advanced distally and inflated to provide distal counter tension, allowing microcatheter retrieval with minimal traction on the vasculature and no further displacement of the onyx cast was observed.Following catheter retrieval, the balloon was deflated and removed.Post-extraction right ica angiography demonstrated mild vasospasm of the right mca, without evidence of extraluminal contrast extravasation or other arterial injury.Verapamil (5 mg in 20 cc of saline) was injected into the right ica and angiography demonstrated resolution of vasospasm.

• 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: 15088281
• MDR Text Key: 301556695
• Report Number: 2029214-2022-01222
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male