MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; COILS

Model Number	100408HFRM-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was delivered to the base of the aneurysm, upon delivering the coil the resistance was felt (before reaching the 'zebra' marker).While the coil was being removed, it detached and got stuck in the microcatheter.
Additional Manufacturer Narrative
A search for non-conformance's 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.The device was stated to be available for evaluation but has not yet been returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.If the device is returned at a later date, an investigation will be performed and a supplemental report will be submitted with the findings.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher coil and implant coil stretched.The pusher was returned partially stuck within the microcatheter, which is consistent with the condition described in the reported event; however, the implant was found to be attached to the pusher upon receipt.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported premature detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched pusher and implant, but stretching is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The microcatheter was not found damaged and would not have caused or contributed to the reported complaint.
Event or Problem Description
It was reported that the microcatheter was delivered to the base of the aneurysm, upon delivering the coil the resistance was felt (before reaching the 'zebra' marker).While the coil was being removed, it detached and got stuck in the microcatheter.Additional information: the clinic informed us that the situation had no negative impact on the patient.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: COILS
• 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: 21877967
• Report Number: 2032493-2025-90094
• Device Sequence Number: 7865296
• Product Code: HCG
• UDI-Device Identifier: 00816777023513
• UDI-Public: (01)00816777023513(11)241011(17)290930(10)0000729777
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 100408HFRM-V-A2
• Device Lot Number: 0000729777
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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
• Patient Sex: Unknown