MAUDE Adverse Event Report: MICROVENTION, INC. AZUR DETACHABLE 35 SYSTEMS; EMBOLIZATION COIL

Model Number	45-450815
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature.It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.Per the instructions for use: potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it was reported not available.Reference: mvi: (b)(4).
Event or Problem Description
It was reported that during an embolization treatment of an aneurysm, the coil prematurely detached within the catheter.The coil was pushed to the target site and the delivery pusher and catheter were removed successfully as a system.No patient harm or injury was reported.

• Brand Name: AZUR DETACHABLE 35 SYSTEMS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5658121
• Report Number: 2032493-2016-00100
• Device Sequence Number: 13540764
• Product Code: KRD
• UDI-Device Identifier: 00810170014949
• UDI-Public: (01)00810170014949(11)151022(17)201022(10)151022GC1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2016

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: 10/22/2020
• Device Model Number: 45-450815
• Device Lot Number: 151022GC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2016
• Initial Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1