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

Model Number	45-750617
Medical Device Problem Codes	Unintended Movement (3026); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: procedure was a pre-evar embolization of the left internal iliac.Right groin access, 5f x 45cm guiding sheath and 4f x 65cm non-taper angled cathether.The first 6 x 9 cm azur cx was deployed easily and successfully.The second 6 x 17 cm had some difficulty advancing out of the the 4f catheter.The physician tried to advance and then noted that the coil had detached.Used a guidewire to try and advance the coil, but was unable.The 4f catheter and coil were removed together, however the second coil grabbed the first fully deployed coil, so both coils were completely removed from the body.For case completion, a new catheter was inserted and multiple azur cx coils were successfully delivered.The case was successful.Patient is stable.
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Two implants were returned separated from the pusher, which is consistent with the claim that complaint device pulled a previously detached coil out of the target site.The pusher was not returned for evaluation.The investigation found the first implant's monofilament profiled a mushroom shape, which indicates the implant successfully experienced thermal detachment.The investigation of the second implant found the implant stretched and the monofilament at the tie knot showed a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The broken monofilament of the second implant is consistent with the device experiencing a premature detachment as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but the damages is consistent with the device experiencing forces exceeding the implant's yield strength.The investigation of the returned catheter did not find any damage or other anomaly that would have caused or contributed to the reported complaint.
Event or Problem Description
No additional information received regarding the event.

• 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: 24393557
• Report Number: 2032493-2026-00104
• Device Sequence Number: 18767882
• Product Code: KRD
• UDI-Device Identifier: 00812636021041
• UDI-Public: (01)00812636021041(11)230524(17)280430(10)0000369455
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/11/2026

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: 45-750617
• Device Lot Number: 0000369455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: 4F X 65CM NON-TAPER ANGLED GLIDECATH.; 5F X 45CM DESTINATION SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown