MAUDE Adverse Event Report: MicroVention, Inc. Azur CX Detachable; Device, Vascular, for Promoting Embolization

Model Number	45-752039
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a pelvic congestion embolization in an 8mm vessel, an embolization coil implant, reported on a separate report, deployed prematurely in the glidecath and did not advance from the catheter into the vessel.The catheter was removed from the patient and the coil was pulled from the catheter outside of the body.The catheter was reintroduced and this device, a 16mm 0.035 cx coil, was opened.The same premature deployment occurred with this coil.The catheter was removed and the second coil was pulled from the catheter outside of the body.At this point the catheter was replaced with a different glidecath and the procedure continued.All coils delivered with no issues before this event and all further coils used after the catheter was replaced also delivered with no issues.The patient was not harmed.Procedure was successful.Patient is stable.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for analysis.However, the device has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use identifies premature coil separation as a potential complication associated with use of the device.

• Brand Name: Azur CX Detachable
• Common Device Name: Device, Vascular, for Promoting Embolization
• Manufacturer (Section D): MicroVention, Inc.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; +1(714)247-8000
• MDR Report Key: 50766757
• Report Number: 2032493-2026-08231
• Device Sequence Number: 9149221
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: 00812636021102
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Health Professional
• Device Model Number: 45-752039
• Device Catalogue Number: 45-752039
• Device Lot Number: 0001121779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: glidecath
• Patient Sex: Unknown