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

Model Number	45-480420-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature.It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.Per the instructions for use: potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.This device involved in this event was reported discarded.The root cause of this incident cannot be determined or confirmed.(b)(4).
Event or Problem Description
It was reported that during the treatment of an aneurysm, the embolization coil prematurely detached or broke within the microcatheter.The devices were reported discarded.No harm or injury occurred as a result of this incident.The patient was reported to be in good condition.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia ave; tustin CA 92780
• MDR Report Key: 5439374
• Report Number: 2032493-2016-00021
• Device Sequence Number: 10903800
• Product Code: KRD
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)151008(17)201008(10)151008LC1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• 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): 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/08/2020
• Device Model Number: 45-480420-L
• Device Lot Number: 151008LC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2016
• Initial Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1