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

Model Number	45-651026
Medical Device Problem Codes	Device Issue (2379); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/10/2016
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 investigation and information provided.This complaint cannot be determined or confirmed as the device was reported not available for evaluation.The likely cause of this complaint is unknown.Mvi ref: (b)(4).
Event or Problem Description
It was reported that during treatment of an aneurysm, in an attempt to "force" the coil through the tortuosity of the vasculature, the coil prematurely detached within the microcatheter.The coil was removed successfully with the microcatheter.Additional coils were deployed successfully.No patient harm or injury was incurred as a result of this complaint.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5559625
• Report Number: 2032493-2016-00065
• Device Sequence Number: 10886239
• Product Code: KRD
• UDI-Device Identifier: 00810170016103
• UDI-Public: (01)00810170016103(11)151026(17)201026(10)151026JC3
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• 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
• Report Date (Section B): 03/10/2016

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: 10/26/2020
• Device Model Number: 45-651026
• Device Lot Number: 151026JC3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1