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

Model Number	45-651434
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	09/25/2017
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 review was performed and there were no similar complaints for this lot number.The device was not returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) warns: "do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the azur-d system, and check for damage" and "advance and retract the azur-d system device slowly and smoothly.Remove the entire azur-d system if excessive friction is noted.".
Event or Problem Description
It was reported that during the treatment of a distal splenic aneurysm, the coil got stuck at the tip of the microcatheter.When the coil was pushed harder, the pusher wire separated from the coil and the coil then detached in the microcatheter.An attempt was made to push the coil into the aneurysm with a guidewire; however, the coil remained in the microcatheter.Both segments of the coil were withdrawn together with the microcatheter, and removed in their entirety.There was no reported intervention or patient injury.The patient is reported to be stable.

• Brand Name: AZUR DETACHABLE FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6985631
• Report Number: 2032493-2017-00270
• Device Sequence Number: 648968
• Product Code: KRD
• UDI-Device Identifier: 00810170016127
• UDI-Public: (01)00810170016127(11)160203(17)210203(10)160203QC1
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: 02/03/2021
• Device Model Number: 45-651434
• Device Catalogue Number: 45-651434
• Device Lot Number: 160203QC1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR