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

Model Number	45-480420-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved 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 has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that resistance was encountered in the microcatheter while placing the coil in the aneurysm.During an attempt to remove the coil, the coil detached from the pusher wire in the microcatheter.The coil was put into the aneurysm with the pusher wire and remains implanted.There was no reported patient injury.The patient is reported to be good.
Additional Manufacturer Narrative
The pusher was returned for analysis; the implant coil was not returned.Visual analysis revealed that there was no damage noted on the pusher.The tie-knot at the pusher attachment section was noted to be intact.The attachment tether had a 1 inch rebound length from the distal heather coil section.Based on the investigation, the detached coil cannot be verified.The pusher was noted to be in conformance; however, with absence of the coil, could not confirm the type of detachment.

• 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: 7368170
• Report Number: 2032493-2018-00053
• Device Sequence Number: 2156175
• Product Code: HCG
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926(11)170407(17)220331(10)170407LC3
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 45-480420-L
• Device Catalogue Number: 45-480420
• Device Lot Number: 170407LC3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1