MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-481020-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided.The root cause of this complaint cannot be determined.No portion of the device was reported available.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during the treatment of an aneurysm, the coil broke or prematurely detached within the microcatheter.The coil was pushed out to the intended site using a syringe.This is 1 of 2 devices reported during this incident.The other is reported in 2032493-2016-00191 ((b)(4)) no harm or injury was reported due to this incident.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5885867
• Report Number: 2032493-2016-00190
• Device Sequence Number: 635867
• Product Code: KRD
• UDI-Device Identifier: 00810170018015
• UDI-Public: (01)00810170018015(11)151116(17)201116(10)151116LC6
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/16/2020
• Device Model Number: 45-481020-L
• Device Lot Number: 151116LC6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2016
• Initial Report FDA Received Date: 08/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention