MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACHABLE HYDRO; EMBOLIZATION COIL

Model Number	45-480410-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the approved device history records indicate the device met all release criteria.The device was not returned to the manufacturer; therefore a device 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 during an attempt to place a coil in the gastroduodenal artery, the coil disengaged and got stuck in the microcatheter.The coil and the microcatheter were removed together, and another microcatheter and coils were used for the procedure.There was no reported patient injury.

• Brand Name: AZUR-18 DETACHABLE HYDRO
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5982023
• Report Number: 2032493-2016-00229
• Device Sequence Number: 13642803
• Product Code: KRD
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)160216(17)210216(10)160216LC2
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/29/2016

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: 02/16/2021
• Device Model Number: 45-480410-L
• Device Lot Number: 160216LC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.8 PROGREAT MICROCATHETER