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

Model Number	45-481015-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device will not be returned for evaluation as it was not available.An evaluation of the actual complaint device could not be performed.Based on the information provided, the root cause of this complaint could not be determined.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.(b)(4).
Event or Problem Description
It was reported a coil was deployed but would not take correct shape or desired position.After multiple manipulation attempts, the coil separated from pusher wire inside the microcatheter.Both coil and microcatheter was safely removed from the patient.No patient injury was reported with this event.

• 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: 6203399
• Report Number: 2032493-2016-00305
• Device Sequence Number: 19074193
• Product Code: KRD
• UDI-Device Identifier: 00810170018008
• UDI-Public: (01)00810170018008(11)160615(17)210615(10)160615LC1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2016

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: 06/14/2021
• Device Model Number: 45-481015-L
• Device Lot Number: 160615LC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 165