MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; EMBOLIZATION COIL

Model Number	45-481010-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2016
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.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 unexpectedly detached from the pusher wire within the microcatheter without use of the detachment controller.The microcatheter was removed with the coil in its entirety from the patient without further incident.There was no reported patient injury.

• Brand Name: AZUR-18 DETACH PLATINUM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6149664
• Report Number: 2032493-2016-00294
• Device Sequence Number: 18936356
• Product Code: KRD
• UDI-Device Identifier: 00810170017995
• UDI-Public: (01)00810170017995(11)151223(17)201223(10)151223LC3
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2016

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: 12/23/2020
• Device Model Number: 45-481010-L
• Device Lot Number: 151223LC3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1