MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL-10-AV; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	7310-0515-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
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.Investigation conclusion: the investigation of the returned coil system found the implant stretched at the proximal section, damaged, and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.Further inspection found the pusher bodycoil offset/overlapping at approximately 39cm from the pusher heater coil, and the pusher hypotube bent at the proximal section.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 implant and pusher damage, 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.
Event or Problem Description
As reported: during mca aneurysm coiling, the physician was using this hydrofill coil when it became loose from the pusher wire in the distal portion of the headway duo before reaching the targeted aneurysm.The duo was pulled out with the coil inside and they were able to push the coil out of the duo.Another coil was used and the case continued as planned with no injury to the patient.No other incident information was provided.

• Brand Name: HYDROFILL-10-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: 22929690
• Report Number: 2032493-2025-90451
• Device Sequence Number: 13350653
• Product Code: KRD
• UDI-Device Identifier: 00816777023391
• UDI-Public: (01)00816777023391(11)250414(17)300331(10)0001060767
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: 7310-0515-A2
• Device Lot Number: 0001060767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• 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: 08/06/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: HEADWAY DUO, DETAILS UNKNOWN
• Patient Sex: Unknown