MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-480305
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	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the 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.The device will not be returned for evaluation; therefore, a product analysis will not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that during positioning of an embolization coil, the coil did not detach.The physician was unable to re-introduce the coil into the sheath to remove it from the artery.As a result, the coil was "forcefully" detached.The procedure was aborted.There was no reported intervention or patient injury.The patient was reported to be doing well.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7401668
• Report Number: 2032493-2018-00063
• Device Sequence Number: 10907927
• Product Code: HCG
• UDI-Device Identifier: 00810170017872
• UDI-Public: (01)00810170017872(11)160311(17)210311(10)160311LC2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 03/11/2021
• Device Model Number: 45-480305
• Device Catalogue Number: 45-480305
• Device Lot Number: 160311LC2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR