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

Model Number	45-652050
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided.The root cause of this complaint cannot be determined.No portion of the device was reported available.(b)(4).
Event or Problem Description
It was reported that during an embolization treatment, the coil would not fully advance from the microcatheter.Upon withdrawal of the coil, it prematurely detached from the delivery pusher within the microcatheter.A bentson wire was used to try to push the coil out (advance) from the microcatheter unsuccessfully.The catheter was removed and in doing so the coil partially deployed with in the vessel bifurcation.The other portion of the coil was pulled with the sheath.The coil was pulled and stretched until it was completely removed.The entire coil was removed in one piece by stretching.No harm or injury was reported due to this incident.

• 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: 5857811
• Report Number: 2032493-2016-00184
• Device Sequence Number: 414674
• Product Code: HCG
• UDI-Device Identifier: 00810170016158
• UDI-Public: (01)00810170016158(11)151110(17)201110(10)151110EC1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 11/10/2020
• Device Model Number: 45-652050
• Device Lot Number: 151110EC1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention