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

Model Number	45-750609
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer.The lot number was provided and the device history records are being reviewed.The investigation is currently underway.
Event or Problem Description
It was reported that an attempt was made to resheath and remove an azur embolization coil.During retraction of the coil, the coil detached from the pusher wire inside the catheter.The pusher wire was pulled out of the catheter, and the detached coil was then removed along with the catheter as it was withdrawn from the patient.There was no reported patient injury.The patient is reported to be stable.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6303097
• Report Number: 2032493-2017-00036
• Device Sequence Number: 303133
• Product Code: KRD
• UDI-Device Identifier: 00812636021010
• UDI-Public: (01)00812636021010(11)160425(17)210425(10)16042511
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: 04/25/2021
• Device Model Number: 45-750609
• Device Lot Number: 16042511
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1