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

Model Number 105-5056

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The marathon micro catheter was returned for analysis.No issues or irregularities were observed with the marathon micro catheter hub.The marathon micro catheter was found to be separated at ~88.1cm from the distal tip.The outer tubing and inner liner were found to be separated at the proximal end of the fluoro marker, retained by the inner wire, at ~88.1cm from the distal tip.The separated ends did not exhibit plastic deformation (jagged edges, necking, stretching).The marathon proximal segment was flushed and water exited from the proximal separated end.No other anomalies were observed.The investigation is not completed.Once the investigation is complete, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the position of the marker point in the middle of the microcatheter was bent and broken and could not be used normally.The microcatheter¿s material was noted to be separated approximately three quarters from one end.There was no damage to the marker band.The damage was found after opening the package and removing it from the protective cover.The patient was undergoing preoperative embolization of the superior sagittal sinus tumor.The microcatheter was not used.No patient injury was reported as a result of the event.

Manufacturer Narrative

Event occurred during an embolization procedure to treat a superior sagittal sinus tumor.The marathon micro catheter was returned for analysis.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed; however, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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. 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: 7409858
• MDR Text Key: 105249671
• Report Number: 2029214-2018-00261
• Device Sequence Number: 1
• Product Code: KRA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 105-5056
• Device Lot Number: A557704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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 Age: 31 YR
• Patient Weight: 55