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

Model Number	45-751019
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician regained access into the left internal iliac with a 4fr glide-catheter to the bifurcation.After flushing catheter, a second 10 x 19cm 035 cx coil was opened and inserted and started elongating and not forming.I mentioned that coil appears oversized.At that time the doctor again indicated that the coil was off the pusher wire.He was able to remove the coil without removing the catheter when it was confirmed the coil was stretched out.The physician was able to remove by pulling on the pusher wire and it was ¿strung out".The doctor then decided to go with the microcatheter system with no other coil issues.No harm or blood loss for the patient.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, however, 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.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.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched at the proximal section and stretched/deformed at the distal end, which is consistent with the condition described in the reported event; however, the implant was still attached to the pusher upon receipt.Due to the stretched and deformed condition of the returned implant, the outer diameter of the implant could not be accurately measured to assess the alleged oversizing issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing forces exceeding its yield strength.The catheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.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.¿based on our investigation findings and clarifying information received from the reporter, there was no coil detachment malfunction.The coil was stretched.Therefore, mvi no longer considers this event a reportable malfunction event¿.Correction: see d10.

• 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: 23103003
• Report Number: 2032493-2025-90504
• Device Sequence Number: 15777385
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: 00812636021072
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/04/2025

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: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 0000725243
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: 4FR GLIDE CATHETER.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White