MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; EMBOLIZATION COIL

Model Number	45-782040-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	10/10/2017
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 coil remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that resistance was encountered during placement of the 6th embolization coil in the distal splenic artery.The coil unexpectedly detached in the microcatheter.The coil was pushed into the intended area with a guidewire.There was no reported patient injury or intervention.The patient is reported to be stable.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7009507
• Report Number: 2032493-2017-00282
• Device Sequence Number: 13749076
• Product Code: KRD
• UDI-Device Identifier: 00810170018404
• UDI-Public: (01)00810170018404(11)161119(17)211031(10)161119LC3
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 10/31/2021
• Device Model Number: 45-782040-L
• Device Catalogue Number: 45-782040
• Device Lot Number: 161119LC3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR