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

Model Number	45-480204-L
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an embolization treatment, the coil detached as it was advanced out of the catheter.The coil was left implanted in the intended area.There was no reported intervention or patient injury.The patient is reported to be good.
Additional Manufacturer Narrative
The pusher was returned without the coil.The distal segment of the pusher was noted to be intact, with no visible evidence of damage.The monofilament was noted to be inside of the pusher.The broken end of the monofilament is indicative of a tensile failure.Based on the investigation, the complaint of a broken coil could not be confirmed.The root cause of the broken coil is unknown; however, the damage to the device exhibited that it was subjected to excessive tensile force that exceeded its maximum strength specification of the monofilament.

• 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: 7133929
• Report Number: 2032493-2017-00335
• Device Sequence Number: 11065495
• Product Code: KRD
• UDI-Device Identifier: 00810170017858
• UDI-Public: (01)00810170017858(11)170303(17)220228(10)170303LC3
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 45-480204-L
• Device Catalogue Number: 45-480204
• Device Lot Number: 13012520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1