MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Infarction, Cerebral (1771); Foreign Body In Patient (2687)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined.The distal marker band remains in the patient's distal cerebral artery.Communication has been made for the device return and a supplemental will be sent once the device is retuned and evaluated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during brain tumor (cerebellar infarction) / embolization, the marathon microcatheter and the mirage guidewire were navigated to the treating location, however, the marker of the marathon microcatheter could not be seen on image.The marathon was removed from the patient, and the physician noticed the marker was missing.New device was used to continue with the procedure.The procedure was completed without further issues, but a foreign material that appeared like the marker was identified on an image of the posterior interior cerebral artery (pica) distal.The patient was reported to have been asymptomatic.The patient was undergoing embolization of a brain tumor (cerebellar infarction).The physician commented the marker might have been disengaged when he re-inserted the marathon microcatheter through y connector as the marathon microcatheter was bent upon insertion at the time of the initial insertion.Information regarding customer shaping the catheter tip.Preparation of devices according to ifu, and maintaining continuous flush were not available.The catheter was briefly checked prior to use and no damage was found.The details of the patient¿s vasculature were not disclosed by the customer.

Manufacturer Narrative

Updated describe event or problem.Updated evaluation codes.Summary of investigation: the marathon micro catheter was returned for analysis.No damages or irregularities were found with the marathon micro catheter hub.No bends or kinks were found with the marathon micro catheter body.The marathon micro catheter distal end does not appear to be bent or shaped.Approximately 0.6 mm of the distal tip and marker band were found missing from the marathon micro catheter.It is possible this segment remains within the patient.The tubing material at the broken end exhibited with jagged edges and stretching.The marathon micro catheter was flushed, water and blood exited from the distal end.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of "marker band dislodged" was confirmed as the distal marker band and tip of the marathon micro catheter was found to be separated and missing.The broken end exhibited plastic deformation of the tubing material (jagged edges and stretching) which indicates that catheter separated when pulled and exceeding the tensile strength of the tubing material.It is possible the tip became separated during re-insertion of the marathon micro catheter through y connector as the tip was reported to be bent.It is not known if a guidewire, stylet, and/or introducer sheath were used to assist with the insertion of the micro catheter in to the hub.All products are 100% inspected for damages and irregularities during manufacture.Therefore, manufacturing has been ruled out as a potential cause.As noted in the marathon ifu (instructions for use): ¿inspect the catheter prior to use to verify that it is undamaged.To assist with insertion of the microcatheter in to the hub, the following accessories may be used: a guidewire, stylet, and/or introducer sheath.Advance the stylet or guidewire through the catheter, keeping the catheter body straight; close the one-way stop-cock; loosen the hemostatic valve; introduce the catheter through the hemostatic adapter; tighten the valve around the catheter to prevent backflow, but allowing some movement through the valve by the catheter; open the one-way stop-cock; advance the catheter such that the stylet or guidewire remains in the guiding catheter; once the catheter has been advanced to the end of the guiding catheter, if using a stylet withdraw the stylet from the catheter.In addition, ¿never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy.Excessive force against resistance may result in damage to the device or vessel perforation.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Received additional information stating that the exact location of where the microcatheter was to be delivered was not available, but the physician was going to deliver the catheter somewhere within posterior circulation.The physician commented that he felt the catheter was caught by the y connector, and he was thinking that the marker was detached there and moved as flushing and administration of contrast medium.Also, it was reported that it could not be confirmed if only the marker was separated or the distal end (with marker) of the microcatheter was separated, but the marker was found located at the distal end of pica, and the physician was thinking that the separated piece caused the cerebellar infarction.The physician was planning to use nbca but not actually used for the procedure due to the issue.The physician noticed the issue before using nbca, and he used another device to continue.The patient suffered a cerebellar infarction due to the issue, and current condition is reported as not recovered.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7235274
• MDR Text Key: 98833400
• Report Number: 2029214-2018-00073
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Model Number: 105-5056
• Device Lot Number: A515731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability