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	08/18/2016
Type of Reportable Event	Malfunction
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.Reference mvi: (b)(4).
Event or Problem Description
It was reported that during a transcaval coiling treatment, difficulty during advancement of the catheter was encountered.The site was accessed and coils were placed into catheter successfully.The coil in complaint would not advance out of the catheter tip.Upon withdrawal, the coil prematurely detached from the delivery pusher.The coil could not be pushed or flushed.The device was pulled from the catheter and reported to stretch.The device was removed and the same catheter was used to deploy additional coils.No additional intervention was reported.No patient injury was incurred 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: 5934713
• Report Number: 2032493-2016-00208
• Device Sequence Number: 10768691
• Product Code: KRD
• 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): 08/18/2016

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: 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: 08/12/2016
• Initial Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR