MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 DETACHABLE HELICAL HYDROCOIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-480410-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction

• Brand Name: AZUR 18 DETACHABLE HELICAL HYDROCOIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 25830032
• Report Number: 2032493-2026-08070
• Device Sequence Number: 10411705
• Product Code: KRD
• UDI-Device Identifier: 00810170017902
• UDI-Public: (01)00810170017902(11)250625(17)300531(10)0001158026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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: 45-480410-L
• Device Lot Number: 0001158026
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown