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

Catalog Number 105-5098-150

Device Problems Failure to Deliver (2338); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2014

Event Type  malfunction  

Event Description

The patient was undergoing an emergent cerebral angiogram/mechanical thrombectomy/thrombolysis.The catheter did not perform correctly.The inner core prevented the wire from passing correctly.Another catheter was used and the patient was not harmed.

• Brand Name: ORION
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 3628533
• MDR Text Key: 4180295
• Report Number: 3628533
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 105-5098-150
• Device Lot Number: 9695150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Patient Sequence Number: 1
• Treatment: NO APPLICABLE
• Patient Age: 62 YR