MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; EMBOLIZATION COIL

Model Number	45-480302-L
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the approved device history records indicated the lot met all release criteria.The lot number was provided.A lot history trending review was performed and there are no similar complaints for this lot number.The device involved in this event has not been returned, no evaluation provided.The possible root cause of this complaint cannot be determined; the device was not returned for evaluation.
Event or Problem Description
It was reported the coil prematurely detached during use on patient/during placement.No patient injury reported.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6071380
• Report Number: 2032493-2016-00265
• Device Sequence Number: 814126
• Product Code: KRD
• UDI-Device Identifier: 00810170017865
• UDI-Public: (01)00810170017865(11)160505(17)210505(10)160505LC2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2016

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: 05/04/2021
• Device Model Number: 45-480302-L
• Device Lot Number: 160505LC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1