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

Model Number	45-781238
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are three coils associated with the reported event.This report addresses the second coil.The first coil is referenced under mfr report # 2032493-2025-90481.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.
Event or Problem Description
It was reported that upon gaining access to the aneurysm, the coil was prepped and introduced into the microcatheter and when it encountered the gentle curves of the splenic artery it began to bind.The coil was removed and the microcatheter was flushed.The physician was able to remove 1/3 of the coil out, but upon attempt to position the coil, it became detached from the pusher wire.The entire micro system was removed.It was reported that this issue occurred with three separate coils during the case.The physician switched to a competitor's coils and was able to successfully treat the aneurysm.There was no patient injury reported.The patient recovered well without issues.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Corrected information provided in h6 and h11.The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.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.

• Brand Name: AZUR CX DETACHABLE
• 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 ; 7142478000
• MDR Report Key: 23048166
• Report Number: 2032493-2025-90482
• Device Sequence Number: 9741373
• Product Code: KRD
• UDI-Device Identifier: 00810170018367
• UDI-Public: (01)00810170018367(11)240425(17)290331(10)0000585650
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2025

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: 45-781238
• Device Lot Number: 0000585650
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/14/2025
• Supplement Report FDA Received Date: 11/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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