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

Model Number UNK-NV-MARATHON

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Rasmus h.Dahl, markus holtmannspotter, henrik gutte, marie cortsen, john hauerberg, goetz benndorf.Snaring of a glued microcatheter during embolization of an arteriovenous malformation with n-butyl cyanoacrylate.Doi:10.1016/j.Wneu.2018.08.120 medtronic literature review found a report of a patient complication during the use of marathon.A (b)(6) woman presented because of headaches and vomiting for 11 days.She initially underwent diagnostic computed tomography, and a large intraventricular hemorrhage was found.Computed tomographic angiography and digital subtraction angiography revealed a right choroidal avm (spetzler-martin grade 4) with deep venous drainage and a prenidal aneurysm arising from the distal anterior choroidal artery (acha).The aneurysm was considered the acute bleeding source, and the patient elected to proceed with coil occlusion to be followed by staged nidus embolization.A marathon microcatheter (medtronic, minneapolis, minnesota, usa) was navigated distally to embolize a posterior nidus compartment using acrylic glue.A mixture of 33% nbca (glubran, gem srl, viareggio, italy) and 67% ethiodized oil (lipiodol, guerbet, aulnay-sous-bois, france) was prepared, and 0.2mlof the nbcamixture was injected under biplane subtracted fluoroscopy (blank road map).During this injection, reflux occurred earlier than expected and before relevant nidus penetration and glued the catheter tip rapidly into the distal feeder.Immediate attempts to carefully withdraw the microcatheter by simple pulling of its proximal end failed.Because leaving the microcatheter in the acha was considered exposing the patient to a significant risk of thromboembolic complications in a sensitive territory, endovascular catheter removal was discussed in our team and then performed.First, a buddy-catheter technique 10 using a second microcatheter (headway duo, microvention) that was advanced in parallel to the marathon into the distal acha was attempted but failed to free the glued microcatheter.Therefore, the hub of the marathon microcatheter was cut off allowing for removal of the sofia 55 catheter.Then, a 2-mm amplatz goose-neck microsnare (medtronic) was slid over the end of the entrapped microcatheter and slowly advanced along this catheter to its distal end.This was supported by slightly pulling back the entrapped marathon to straighten the course of the acha.The snare was then tightened around the catheter¿s tip as closely as possible to the nbca cast.Repeated, gentle, and simultaneous pulling of both the trapped microcatheter and the snare was applied over approximately 10 minutes.Whereas it appeared not possible to grab the glue surrounding the catheter itself to break it off, repeated alternate pulling and relaxing the system eventually resulted in freeing and removal of the microcatheter.Immediate postprocedure digital subtraction angiography run showed no noticeable spasm, dissection, or extravasation.The patient woke up with no new deficits and had an uneventful postoperative course.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9218382
• MDR Text Key: 207608380
• Report Number: 2029214-2019-01053
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

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: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/22/2019
• 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