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

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2014

Event Type  Death  

Event Description

After onyx injection, the catheter was immediately withdrawn, but the catheter tip was affixed in the cerebral vessel and the catheter fractured on withdrawal.The proximal end of the catheter fragment was located in the right supraclinoid internal carotid artery.

• Brand Name: MARATHON FLOW DIRECTED MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine, CA 92618
• MDR Report Key: 4293267
• MDR Text Key: 16305137
• Report Number: 4293267
• Device Sequence Number: 1
• Product Code: KRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR