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

Model Number	45-452030
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	11/08/2017
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 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 system, and check for damage" and "advance and retract the azur system slowly and smoothly.Remove the entire azur system if excessive friction is noted.".
Event or Problem Description
It was reported that during a transjugular intrahepatic portosystemic shunt (tips) procedure, an embolization coil got stuck in a 5f catheter during advancement into a gastric varice.An attempt was made to advance the coil against resistance, followed by coil withdrawal and another attempt to advance the coil out of the catheter, at which time the coil detached in the catheter.The coil was removed in its entirety together with the catheter.There was no reported intervention or patient injury.

• 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: 7119429
• Report Number: 2032493-2017-00326
• Device Sequence Number: 781174
• Product Code: KRD
• UDI-Device Identifier: 00810170015045
• UDI-Public: (01)00810170015045(11)170529(17)220430(10)17052953K
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122316
• 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): 11/14/2017

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: 04/30/2022
• Device Model Number: 45-452030
• Device Catalogue Number: 45-452030
• Device Lot Number: 17052953K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1