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

Model Number	45-750824
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: tips procedure with vein embolization.Guiding sheath and 5fr x 100cm angled catheter were in position, coil prepped and catheter flushed.Advanced coil but it would not reach the tip of catheter.Attempted to withdraw coil and felt it detach.Upon inspection, noted that coil had stretched within catheter.Catheter was removed with coil in it.New catheter advanced and procedure continued and completed without issue.The coil detached and stretched inside the microcatheter.The pusher wire was removed prior to the catheter with the coil still inside being removed.No patient injury reported.
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 is in transit to be returned to the manufacturer for evaluation but has not yet been received by the manufacturer.The reported 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.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher's strain relief damaged, and the implant stretched at the proximal section, separated from the pusher, and stuck inside the returned catheter.No indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with 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 physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage and the stretched implant, but the damage is consistent with the device experiencing forces exceeding the strength of the pusher and implant's yield strength.The returned catheter did not exhibit any kinks or damage that would have caused or contributed to the reported advancement issue.
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: 23615262
• Report Number: 2032493-2025-90666
• Device Sequence Number: 10011415
• Product Code: KRD
• UDI-Device Identifier: 00812636021065
• UDI-Public: (01)00812636021065(11)240930(17)290831(10)0000718577
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 45-750824
• Device Lot Number: 0000718577
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: ADVANCED DESTINATION SHEATH.; GLIDECATH 5FR X 100CM ANGLED CATHETER.
• Patient Sex: Unknown