MAUDE Adverse Event Report: MICROVENTION INC. V-TRAK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	7110-0515-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the coil deployed in the microcatheter in the patient by itself without actually being detached.Coil was removed along with the headway 17 microcatheter.Was not left in the patient.The device is available for return and investigation.There was no patient injury.The patient outcome was good.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue/event as described could not be confirmed.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
As reported, the coil deployed in the microcatheter in the patient by itself without actually being detached.Coil was removed along with the headway 17 microcatheter.Was not left in the patient.The device is available for return and investigation.There was no patient injury.The patient outcome was good.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher returned without the implant attached, but no indications of activation using a detachment controller was found on the pusher heater coil.Further inspection found the pusher hypotube kinked.The implant was found stretched at the proximal section, separated from the pusher, and partially stuck within the returned microcatheter.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 pusher kink and stretched implant, but this damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The returned microcatheter was found flattened at 6cm from the distal tip, which may have caused or contributed to the reported complaint.A search for non-conformances 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.H11 - corrections.Corrections made to fields in section d, g5.

• Brand Name: V-TRAK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; microvention, inc.; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21876445
• Report Number: 2032493-2025-90093
• Device Sequence Number: 7653741
• Product Code: KRD
• UDI-Device Identifier: 00816777023681
• UDI-Public: 00816777023681
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 7110-0515-A2
• Device Catalogue Number: 7110-0515
• Device Lot Number: 0000467008
• 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: 04/05/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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: HEADWAY 17 ADVANCED (MV).
• Patient Age: 52 YR
• Patient Sex: Female