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

Model Number	45-751019
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched at the proximal section and separated from the pusher; however, 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 stretched implant, but the damage is consistent with the device experiencing forces exceeding the implant's 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.
Event or Problem Description
No additional information received regarding the event.
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: during a splenic aneurysm coiling, a 6f 4cm sheath was in the splenic artery and a 5f 65cm catheter was into the outflow vessel of the aneurysm sac.The 10mmx19cm 035 azur cx coil was advancing into the vessel, about halfway into the outflow vessel, the coil wasn't forming so they went to pull the coil back and it detached.The doctor used saline to push the coil the rest of the way out of the catheter.They wanted to tuck the rest of the coil out of the catheter, but the wire would not advance into the catheter.The doctor felt resistance.The proximal part of the coil was stuck in the tip of the catheter.The doctor removed the catheter and coil out of the patient.All of the coil was removed.The procedure continued with successful embolization.The coil detached from the pusher wire inside the catheter.Regarding the statement the ¿doctor used saline to push the coil the rest of the way out of the catheter¿, only part of the coil was pushed out with saline, the distal end was still in the proximal part of the catheter.No snare was used to retrieve the coil.When the doctor pulled back the catheter, all of the coil was removed with the catheter, some of the coil was in the catheter and some was out of the tip.The patient left the room in stable condition.

• 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: 22855148
• Report Number: 2032493-2025-90423
• Device Sequence Number: 4418943
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)241014(17)290930(10)0000730980
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 Lot Number: 0000730980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: 5F 65CM C2 GLIDE CATHETER.; 6F 4CM COOK ANSEL2 SHEATH.
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White