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

Model Number	45-780413
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
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 was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that after insertion into the catheter, the coil would not advance.Upon removal, the coil appeared to have separated from the pusher wire.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher and implant were returned for analysis.Investigation into the returned unit found the implant was still attached to the pusher.The implant was in good condition and without damage.The pusher was found to have multiple kinked/bent locations on the hypotube.The gold connector was found to have a minor bend.It is unknown as to whether the damage was the result of handling during use or during shipment.The heater coil was found to be intact, and without signs of thermal detachment.A large section of lead wire separation was noted on the pusher.Based on the reported complaint, it is assumed that the noted "separation" was pertaining to the lead wires, not the implant.Based upon the investigation analysis and available information, the reported complaint of a detached implant was unable to be confirmed as the implant was found attached to the pusher; however, a section of the pusher was found to have lead wire separation.The observed lead wire separation would result in advancement issues in the microcatheter.The root cause of the damage is unknown, but has historically been related to manipulation and forces that exceed the intended level.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8341852
• Report Number: 2032493-2019-00027
• Device Sequence Number: 139981
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: (01)00810170018299(11)180720(17)230630(10)1807205W3
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• 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): 01/16/2019

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: 06/30/2023
• Device Model Number: 45-780413
• Device Catalogue Number: 45-780413
• Device Lot Number: 1807205W3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1