MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO; CATHETER, PERCUTANEOUS

Model Number	MC162156S
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Investigation conclusion: the investigation found the microcatheter returned with a non-terumo neuro guidewire stuck inside the lumen, which is consistent with the alleged product issue.The microcatheter shaft was found snaked underneath the strain relief, which is consistent with resistance when retracting the guidewire.The microcatheter was dissected near the tip of the guidewire, revealing a long segment of delaminated ptfe that appears to be the cause of the resistance.Further investigation found ptfe delamination and exposed coil at the hub transition area.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the exposed coil and delaminated ptfe lining, but these conditions are consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.
Event or Problem Description
As initially reported, during a procedure for a mca aneurysm (3mm x 2.7mm), the physician noticed resistance while advancing the guidewire into the headway duo microcatheter, despite it being properly hydrated before use.The physician decided to replace the device with a new one.The physician changed another new headway duo microcatheter to complete the procedure.The patient was reported to be good.When the device was received and analyzed, the microcatheter exhibited exposed coil at the hub transition area.

• Brand Name: HEADWAY DUO
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 23099559
• Report Number: 2032493-2025-90501
• Device Sequence Number: 18288104
• Product Code: DQY
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)231004(17)260930(10)0000436069
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K120917
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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 Expiration Date: 09/30/2026
• Device Model Number: MC162156S
• Device Lot Number: 0000436069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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
• Patient Sex: Unknown