MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	45-780413-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was stated to be available for return to the manufacturer but it has not yet been returned.The alleged product issue could not be confirmed.If it is received at a later date, an investigation will be performed and a supplemental report will be submitted.The instructions for use identifies premature separation as a potential complication associated with use of the device.
Event or Problem Description
As reported, plug not releasing properly.Removal impossible.Removal via catheter and analysis of plug, plug cut in half.No patient harm reported.
Additional Manufacturer Narrative
The investigation found the implant coil damaged and separated from the pusher with the monofilament exposed.The pusher was not returned for evaluation.The investigation found the exposed monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.As the pusher was not returned, the investigation could not test for or further assess the alleged non-detachment issue described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
See h11 for product investigation.

• Brand Name: AZUR CX 18D-LONGER
• 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; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22800559
• Report Number: 2032493-2025-90398
• Device Sequence Number: 8512389
• Product Code: KRD
• UDI-Device Identifier: 00810170018299
• UDI-Public: 00810170018299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 45-780413-L
• Device Lot Number: 0001033069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown