MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; EMBOLIZATION COIL

Model Number	45-682050-L
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the approved device history records indicated the lot met all release criteria.Based on the available information, the evaluation confirmed the reported complaint as the implant coil is not attached to the delivery pusher.The possible root cause for this complaint may be due to the stretching and tortuous anatomy that led the monofilament / knot to slip from its attachment zone.
Event or Problem Description
It was reported that during an embolization treatment, the coil encountered resistance within the microcatheter as tortuous anatomy was stated.Attempts were made to push and pull the device.During the attempted positioning, the coil prematurely detached from the delivery pusher partially within the vessel and the microcatheter.The entire system was withdrawn without incident.No intervention was taken, no patient injury was incurred.

• Brand Name: AZUR-18 DETACH PLATINUM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6100658
• Report Number: 2032493-2016-00285
• Device Sequence Number: 294380
• Product Code: KRD
• UDI-Device Identifier: 00810170017834
• UDI-Public: (01)00810170017834(11)150929(17)200929(10)150929LC2
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123384
• 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): 10/20/2016

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: 09/29/2020
• Device Model Number: 45-682050-L
• Device Lot Number: 150929LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1