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

Model Number 105-5056

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 10/14/2018

Event Type  malfunction  

Manufacturer Narrative

The marathon micro catheter was returned for analysis.When measured, approximately 25cm of the marathon distal floppy segment was found to be missing.Flash was observed with the marathon micro catheter hub.The missing marathon segment was not returned.The reason for the segment not returning was not provided.The tubing material at the distal broken end exhibited with jagged edges, necking and stretching.Inspection of the remainder of the marathon, apart from the observed separation, there were no other damage or irregularities found with the catheter.The marathon micro catheter was tested with an in-house tapered mandrel.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ could not be confirmed.The broken end of the marathon exhibited plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It is possible high force was used (pushing/pulling); subsequently causing the catheter to separate.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of guidewire resistance in catheter.It was reported that the devices were prepared as indicated in the ifu.It was reported that outside of the patient, the mirage guidewire was inserted into the marathon, but was unable to pass.The marathon was replaced and the guidewire was able to be pass normally.The marathon was suspected to have an occlusion.There were no reports of patient injury in association with this event.The marathon was returned for evaluation.During the analysis the marathon was found to be separated.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine,ca
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 8194939
• MDR Text Key: 131467169
• Report Number: 2029214-2018-01089
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536005914
• UDI-Public: 00847536005914
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: 105-5056
• Device Lot Number: A627187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Date Device Manufactured: 04/10/2018
• 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: 61 YR