MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-18 DETACH PLATINUM; DEVICE NEUROVASCULAR EMBOLIZATION

Model Number	45-682050-L
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while advancing two coils through the microcatheter for embolization of a splenic aneurysm, there was a significant friction encountered between both coils and microcatheter that prevented any further movement.An attempt to reposition the two coils led to their detachment.This situation resulted in an increase in procedure time, with a total of 50 ml contrast agent administered.There was no patient injury reported.A request was made to confirm the amount of time the procedure was delayed and to clarify how the case was completed, but there was no further information received to date.This report addresses the second coil.The first coil is captured under medwatch# 2032493-2026-00084.
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 for evaluation but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
Additional information was received indicating that the procedure was delayed by approximately 20 minutes due to the time required to realize it would not fit, perform testing outside the body, and making another attempt.The case was completed successfully, but no framing coils could be deployed.The physician was able to perform coiling using standard detachable coils.The patient experienced no issues that occurred during or after the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted as additional information was received.The following sections were updated: b1.Deselected adverse event, b2.Deselected other serious (important medical events), b5.Additional information received, h1.Serious injury was changed to malfunction, h6.Impact code 4633 was changed to 2199.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.This report addresses the second coil.The first coil will be captured under medwatch# 2032493-2026-00084.
Additional Manufacturer Narrative
Based on our investigation findings, the coil was kinked and damaged; however, the coil was attached to the delivery pusher upon receipt.There is no premature detachment that occurred.Therefore, mvi no longer considers this event a reportable malfunction event.This report addresses the second coil.The first coil will be captured under medwatch# 2032493-2026-00084.
Event or Problem Description
See h11.

• Brand Name: AZUR-18 DETACH PLATINUM
• Common Device Name: DEVICE NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 24319189
• Report Number: 2032493-2026-00087
• Device Sequence Number: 10153552
• Product Code: HCG
• UDI-Device Identifier: 00810170017834
• UDI-Public: (01)00810170017834(11)250131(17)291231(10)0000956217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050954
• 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,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-682050-L
• Device Lot Number: 0000956217
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 03/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/12/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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