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

Model Number	45-750824
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and the device history records are being reviewed.The device has not yet been returned to the manufacturer.The investigation is currently ongoing.
Event or Problem Description
It was reported that the azur embolization coil detached in the microcatheter.Half of the coil extended outside the microcatheter and half of the coil remained inside the microcatheter.Several attempts were made to push the detached coil out of the microcatheter; however, they were unsuccessful.The microcatheter, delivery system, and the entire coil were removed from the patient.There was no reported patient injury.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6136943
• Report Number: 2032493-2016-00290
• Device Sequence Number: 18912848
• Product Code: KRD
• UDI-Device Identifier: 00812636021027
• UDI-Public: (01)00812636021027(11)160525(17)210525(10)16052511
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/31/2016

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: 05/24/2021
• Device Model Number: 45-750824
• Device Lot Number: 16052511
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1