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

Model Number	45-750824
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported from the hospital to the sales rep, case was gi bleed, 5fr catheter 65cm, was engaged into the ima.The coil was put thru this catheter upon entering the vessel it was evident it was too large for the vessel, upon retracting the coil it begun to sheer apart still staying attached to the pusher wire.A loop snare was used to pull the pusher wire and coil from the pt.Pt condition not affected just added time to case.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation; however, it was not 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.
Additional Manufacturer Narrative
Additional information received and added to b5.Correction: d4 - udi.D10 - device availability.
Event or Problem Description
As reported from the hospital to the sales rep, case was gi bleed, 5fr catheter 65cm, was engaged into the ima.The coil was put thru this catheter upon entering the vessel it was evident it was too large for the vessel, upon retracting the coil it begun to sheer apart still staying attached to the pusher wire.A loop snare was used to pull the pusher wire and coil from the pt.Pt condition not affected just added time to case.Additional complaint information received stated that the issue added 45 mins to case time.Case was completed with interlock and pnumbra coils.
Event or Problem Description
No additional information received regarding the event.Please see h11.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant completely stretched from the proximal end to the distal section, entangled, and separated from the pusher.The pusher was not returned for evaluation.The investigation found the monofilament at the implant tie knot 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 stretching 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.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.

• 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; allso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22559452
• Report Number: 2032493-2025-90343
• Device Sequence Number: 15821098
• Product Code: KRD
• UDI-Device Identifier: 00812636021065
• UDI-Public: 00812636021065
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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: 45-750824
• Device Lot Number: 0000812797
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 08/27/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/15/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR SOS OMNI 65 CM CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown