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

Model Number	45-480305
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned to the manufacturer; therefore, a product evaluation could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during the treatment of a small segment of a hepatic artery branch, resistance was encountered while advancing the coil to the target site.Under fluoroscopic guidance, it was noted that there was no coil on the end of the wire.The pusher wire was removed; however, there was no coil visible.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
Additional information: (d10, h3) device received by manufacturer and analyzed the delivery pusher, introducer sheath, and dispenser hoop were returned for analysis.The microcatheter and implant coil were not returned.The pusher was undamaged and met specifications; the distal section of the pusher (´´heater coil & strain relief´´) were undamaged, and did not have any burn marks (marks produced after a detachment procedure).The distal section of the pusher had blood residual.The monofilament was next to the platinum coil.The pusher was opened at the distal section to verify the monofilament condition.The monofilament did not have a mushroom shape, which would be produced during the v-grip device activation.The monofilament had a tail profile.The pusher's monofilament appeared to have a profile consistent with a tensile break.This tensile break is typically caused when the device experiences forces over specification, likely during retraction if the implant is stuck or experiences friction, and too much force is applied.

• Brand Name: AZUR 18 PERIPHERAL V-TRAK SYSTEM
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8579927
• Report Number: 2032493-2019-00114
• Device Sequence Number: 16528303
• Product Code: HCG
• UDI-Device Identifier: 00810170017872
• UDI-Public: (01)00810170017872(11)180903(17)230831(10)180903526
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K090168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 45-480305
• Device Catalogue Number: 45-480305
• Device Lot Number: 180903526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91