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

Model Number	45-480420-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records are being reviewed indicated the lot met all release criteria.The device was not returned to the manufacturer.; therefore, an evaluation could not be performed.The root cause could not be determined.
Event or Problem Description
It was reported that the azur embolization coil detached unexpectedly without use of the controller.The coil was successfully snared and withdrawn without further incident.The patient is reported to be stable.There was no reported patient injury.

• 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: 6231391
• Report Number: 2032493-2017-00007
• Device Sequence Number: 10951523
• Product Code: KRD
• UDI-Device Identifier: 00810170018039
• UDI-Public: (01)00810170018039(11)161005(17)210930(10)161005LC1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/29/2021
• Device Model Number: 45-480420-L
• Device Lot Number: 161005LC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1