MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 PERIPHERAL V-TRAK SYSTEM; EMBOLIZATION COIL

Model Number	45-480310-L
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The analysis revealed the delivery pusher with the implant coil not attached and the introducer removed.The device was returned for evaluation.The delivery pusher was returned without the implant coil attached.The proximal end of the implant coil was stretched.The delivery pusher was kinked between the attachment bond and the 3cm mark coil.Based on the available information, the reported complaint can be confirmed, as the implant coil is separated from the delivery pusher.The results of the investigation are consistent with the device being exposed to a force that exceeded its maximum tensile specification; however, the exact root cause cannot be determined.
Event or Problem Description
It was reported that coil embolization treatment was attempted on a splenic artery aneurysm.During advancement of the coil in the catheter, resistance was encountered and the coil unexpectedly detached in the catheter before the coil had exited into the patient.The entire coil was removed together with the catheter without incident.There was no reported patient injury.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6370959
• Report Number: 2032493-2017-00045
• Device Sequence Number: 16414352
• Product Code: KRD
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)151006(17)201006(10)151006LC2
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• 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): 01/30/2017

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: 10/06/2020
• Device Model Number: 45-480310-L
• Device Lot Number: 151006LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROGREAT MICROCATHETER