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

Model Number	45-451220
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review indicated there are no other complaints for this lot number.The device was not returned to the manufacturer; therefore, an evaluation could not be performed.Based on the information provided, the root cause of this complaint cannot be determined.
Event or Problem Description
It was reported that the azur embolization coil would not detach.During the attempt to reposition the coil, it detached in the microcatheter.There was no reported patient injury or additional intervention.The procedure continued and was completed successfully without further incident.

• 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: 6049509
• Report Number: 2032493-2016-00246
• Device Sequence Number: 422147
• Product Code: KRD
• UDI-Device Identifier: 00810170014994
• UDI-Public: (01)00810170014994(11)160223(17)210223(10)160223JC2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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: 02/23/2021
• Device Model Number: 45-451220
• Device Lot Number: 160223JC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1