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

Model Number	45-781238-L
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 for evaluation but 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 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
It was reported that spontaneous coil deployment occurred in the vessel lumen before placement in the target vessel.There was no detachment or repositioning of the coil.There was no patient harm reported.
Event or Problem Description
It was reported that spontaneous coil deployment occurred in the vessel lumen before placement in the target vessel.There was no detachment or repositioning of the coil.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation findings now indicates that the coil was attached to the delivery pusher, therefore no premature detachment (spontaneous coil deployment) occurred.The coil was stretched.Therefore, mvi no longer considers this event a reportable malfunction event.Corrections h6 - medical device problem code - remove 4045 - premature separation h6 - medical device problem code - add 1601 - stretched.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA ; PL
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22163825
• Report Number: 2032493-2025-90239
• Device Sequence Number: 15663919
• Product Code: KRD
• UDI-Device Identifier: 00810170018367
• UDI-Public: (01)00810170018367(11)241008(17)290930(10)0000726402
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 Expiration Date: 09/30/2025
• Device Model Number: 45-781238-L
• Device Lot Number: 0000726402
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown