MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL DETACHABLE 3MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	45-480305
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been returned to the manufacturer for analysis.The root cause is unknown.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during retraction of an embolization coil to reposition it in the treatment site, the coil unexpectedly detached.A cut-down was performed to retrieve the detached coil.

• Brand Name: AZUR 18 HYDROCOIL DETACHABLE 3MM X 5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9714818
• Report Number: 2032493-2020-00032
• Device Sequence Number: 18922849
• Product Code: HCG
• UDI-Device Identifier: 00810170017872
• UDI-Public: (01)00810170017872(11)190516(17)240430(10)19051653Z
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 45-480305
• Device Catalogue Number: 45-480305
• Device Lot Number: 19051653Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention