MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-451015
Medical Device Problem Codes	Device Issue (2379); Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it was reported not available.(b)(4).
Event or Problem Description
It was reported from (b)(6) during embolization treatment of a vessel, the coil prematurely detached without the use of the detachment controller.No intervention was reported.No patient harm or injury was reported.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5758893
• Report Number: 2032493-2016-00154
• Device Sequence Number: 18948886
• Product Code: KRD
• UDI-Device Identifier: 00810170014963
• UDI-Public: (01)00810170014963(11)151102(17)201102(10)15110212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2016

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: Physician
• Device Expiration Date: 11/02/2020
• Device Model Number: 45-451015
• Device Lot Number: 15110212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 06/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1