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

Model Number	45-480420-L
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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
It was reported that a competitor base catheter, then a 2.4 microcatheter catheter was used in the celiac then gda.Pushed coil through catheter, after placing 2 competitor coils.The coil of concern got hung up in the catheter and prematurely detached.Was able to reverse suction coil partway into the microcatheter then pull the microcatheter into the base catheter and reverse suction and pull the base catheter out with the coil.No harm to patient.Ended up using gelfoam embolic agent to complete the case.
Additional Manufacturer Narrative
The visual analysis of the returned device found that the implant was not attached to the pusher.The implant was not returned for evaluation.Further inspection found that the pusher corewire was kinked at 24cm from the strain relief.The investigation found the pusher's monofilament to have a broken tip, which indicates that the device experienced a tensile break.The reported complaint is confirmed.The investigation of the returned coil system found the pusher corewire kinked at 24cm from the strain relief and the implant not attached to the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The implant was not returned for evaluation.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 kinked pusher, but the damage is consistent with the device experiencing forces exceeding the 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.
Event or Problem Description
A supplemental report is being submitted to include the investigation findings, see section h11.Also, a correction has been made in section d4 and d11 for the device udi.

• Brand Name: AZUR DETACHABLE HELICAL HYDROCOIL
• 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: 22657102
• Report Number: 2032493-2025-90363
• Device Sequence Number: 18227453
• Product Code: KRD
• UDI-Device Identifier: 00810170017926
• UDI-Public: (01)00810170017926
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K120630
• 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
• Report Date (Section B): 07/29/2025

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-L
• Device Lot Number: 0000456994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: 2.4 PROGREAT.; SIM 1 BASE CATHETER.
• Patient Sex: Unknown