MAUDE Adverse Event Report: MicroVention, Inc. AZUR-35 Detachable Hydro; Device Vascular for Promoting Embolization

Model Number	45-452020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the patient had an abdominal aortic pseudoaneurysm (diameter: 50 mm).During the procedure, a 5f angiographic catheter was used to deliver the first azur 20-30 coil.Significant resistance was encountered during advancement, resulting in separation of the delivery wire from the coil.The angiographic catheter was subsequently withdrawn.A new angiographic catheter was then used, and two azur 20-30 coils were successfully delivered without issue.A covered stent was subsequently deployed, and the procedure was completed successfully.The patient returned safely to the ward, and no harm or adverse clinical impact occurred.Patient condition, stable.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is reported available for return to the manufacturer for analysis.At this time the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.

• Brand Name: AZUR-35 Detachable Hydro
• 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: 50941629
• Report Number: 2032493-2026-08272
• Device Sequence Number: 18822056
• Product Code: KRD
• UDI-Device Identifier: 00810170015038
• UDI-Public: (01)00810170015038
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 45-452020
• Device Lot Number: 0000474866
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male