MAUDE Adverse Event Report: MICROVENTION INC AZUR-18 DETACHABLE HYDROCOIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	45-480420-01
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: gda embolization through 2.4fr progreat coaxial microcatheter.The first 4x20 hydrocoil 18 was flushed, inspected as usual without issue.There was difficulty tracking coil through microcatheter even though there was no tortuosity.The coil then detached inside the microcatheter.The physician clarified that the first coil is being returned.It was too stiff to deliver and seemed to be damaged within the microcatheter.A second 4x20 hydrocoil 18 of the same lot number was flushed, inspected as usual without issue.The second coil tracked easily through the microcatheter, however close to the end of the microcatheter it was observed the coil had detached inside the microcatheter.Upon closer inspection the coil had detached at about 2cm proximally on the pusher wire.The pusher wire was withdrawn from the microcatheter.Numerous wires were used with saline to push the coil and 2cm of fractured pusher wire to the intended location.This coil remains implanted.There was no reported patient injury, updated patient status is ¿stable¿ and no further treatment is planned to address the 2cm pusher implanted.Although requested no further clarification was received.This report captures the detachment malfunction issue with the first coil.The breakage issue with the second coil will be reported under an additional submission.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.The device was stated to be available for return to the manufacturer for evaluation, but has not yet been received.The alleged product detachment issue and incident as described could not be confirmed at this time.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
The detachment malfunction issue with the first coil was reported under this mdr 2032493-2025-90326 the breakage issue with the second coil was reported under mdr 2032493-2025-90327.No additional incident information was provided but the device was received and evaluated.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.Investigation conclusion the investigation of the returned coil system found the implant coil stretched at the proximal end and the pusher kinked at the distal section.However, no section of the pusher was found broken or detached 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 and pusher kink, but the damage is consistent with the device experiencing forces exceeding the implant and pusher's yield strength.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: AZUR-18 DETACHABLE HYDROCOIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 22516602
• Report Number: 2032493-2025-90326
• Device Sequence Number: 8153145
• Product Code: HCG
• UDI-Device Identifier: 00840273200901
• UDI-Public: (01)00840273200901(11)240820(17)290731(10)0000682901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090168
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 45-480420-01
• Device Lot Number: 0000682901
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4FR PROGREAT COAXIAL MICROCATHETER
• Patient Sex: Unknown