MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-18-AV; DEVICE VASCULAR FOR PROMOTING EMBOLIZATION

Model Number	181644HFRM-V-A2
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the coil was implanted via a jailed headway 17 and flow diverter.The detachment controller showed green however, did not sound correct for detachment confirmation.It was thought the coil was detached but it showed that the pusher wire had broken and separated.The implant coil remained attached to the delivery pusher.The broken pusher wire and the coil were removed from the patient with a guidewire and manipulation within the microcatheter.The case was completed with flow diverter only as jailed microcatheter was removed with the coil system.No patient harm was reported.
Additional Manufacturer Narrative
The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.
Additional Manufacturer Narrative
A supplemental report was submitted to correct the device problem code to more appropriate code based on the event description.
Event or Problem Description
A supplemental report is being submitted to make code correction in section h6, device problem code.The code should be: 1069- break.There are no other changes.

• Brand Name: HYDROFRAME-18-AV
• 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: 23382027
• Report Number: 2032493-2025-90603
• Device Sequence Number: 8645101
• Product Code: KRD
• UDI-Device Identifier: 00816777023872
• UDI-Public: (01)00816777023872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 181644HFRM-V-A2
• Device Lot Number: 0000752582
• Was Device Available for Evaluation?: No
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown