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

Model Number	45-781639
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: when treating a splenic artery aneurysm, they probed into the aneurysm with a 90cm guiding sheath and a 2.7fr microcatheter.Everything went well and they were able to place 5 framing coils.Afterwards, they wanted to fill it with cx coils, but the coil would not come out of the microcatheter and kept getting stuck.Regarding the microcatheter, there is no complaint about it, as wires etc.Could be pushed through without any problems.Flushing was also no problem.In the end, the aneurysm was not filled further, but left with the coils that had already been implanted.Unfortunately, the case was not completed satisfactorily ¿ they stopped the procedure when the coil wouldn't pass through the microcatheter, but they would have liked to continue filling with coil.No patient injury reported.
Additional Manufacturer Narrative
A search for non-conformance's 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 a device return attempt.Ongoing attempts will be made for the device return.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.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant coil kinked and deformed, and the pusher kinked at the distal section, which is consistent with the device causing or contributing to the advancement issue within the microcatheter as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant and pusher damage, but the damage is consistent with the device experiencing forces exceeding the implant and pusher's yield strength.The investigation of the microcatheter used with the coil system in the procedure found one of them to be flattened at approximately 15cm from the distal tip, which may have caused or contributed to the reported advancement issue.
Event or Problem Description
Additional information received: no additional procedures have been performed on the patient, and at this time, there are no further interventions planned.The patient has already been discharged.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 24429963
• Report Number: 2032493-2026-00123
• Device Sequence Number: 10393260
• Product Code: KRD
• UDI-Device Identifier: 00810170018381
• UDI-Public: (01)00810170018381(11)240223(17)290131(10)0000533545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 45-781639
• Device Lot Number: 0000533545
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.7FR PROGREAT MICROCATHETER.; 90CM DESTINATION SHEATH.; AZUR CX COIL (MODEL 45-680820, LOT 0001010375).; AZUR CX COIL (MODEL 45-781032, LOT 0001101198).; AZUR CX COIL (MODEL 45-781434, LOT 0001145062).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female