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

Model Number	45-480615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
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 to the manufacturer.The investigation is currently underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment, the coil detached without use of the controller.Both segments of the coil and microcatheter were removed from the patient.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device was returned with pusher and implant for analysis.The pusher was noted to be bent, the heater coil was within specifications.The implant coil was stretched.Based on the investigation, the complaint was able to be confirmed.The broken monofilament indicated that the coil separated from the pusher due to tensile force.This type of condition can occur when the device is subjected to excessive force during handling, preparation, or manipulation during the procedure.The investigation confirmed that the implant separated from the pusher, but it was not caused by the normal detachment function.

• 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: 8196914
• Report Number: 2032493-2018-00286
• Device Sequence Number: 2325300
• Product Code: HCG
• UDI-Device Identifier: 00810170017940
• UDI-Public: (01)00810170017940(11)170824(17)220731(10)170824524
• 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,Followup
• Report Date (Section B): 11/29/2018

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 45-480615
• Device Catalogue Number: 45-480615
• Device Lot Number: 170824524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1