MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 35 DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-751324
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: dr started to position the implant coil.As he was advancing the coil, mid-catheter, he encountered a kink in the parent catheter.Operator tried several times to get the coil past the kink but was unsuccessful.While doing this, the coil detached prematurely in the parent catheter, not in the patient.Coil was successfully pulled out in parent catheter, and a new coil was used.Case completed with different coils.Procedure performed: rt hypogastric embo aaa.Patient did well.No harm to the patient.
Event or Problem Description
No additional information received regarding the event.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher kinked within the outer sleeve at the distal section and the implant stretched at the proximal section and separated from the pusher; however, no indication of activation using a detachment controller was found on the pusher heater coil.Further investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing forces exceeding the tensile strength of the monofilament, causing the implant to separate from the pusher.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 its yield strength.The catheter used during the procedure was reported to be kinked, which may have caused or contributed to the reported complaint.

• Brand Name: AZUR CX 35 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: 23702417
• Report Number: 2032493-2025-90682
• Device Sequence Number: 10691550
• Product Code: KRD
• UDI-Device Identifier: 00812636021089
• UDI-Public: (01)00812636021089(11)240716(17)290630(10)0000653713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 01/15/2026

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: 45-751324
• Device Lot Number: 0000653713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: 5FR ANGLED GLIDECATH.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White