MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-DUO 16; CATHETER PERCUTANEOUS

Model Number	MC162156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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.The device has been returned to the manufacturer for analysis however, the investigation is pending completion.The alleged product issue cannot be confirmed at this time.The investigation findings will be included in a supplemental mdr report.
Event or Problem Description
As reported, the 014 wire would not go through the hub of the headway duo.Additional information received from the fda indicated, (b)(4): event 1, lot: 0001027774.During prep of the catheter, the md was unable to pass the wire through the catheter.There is a defect in the hub that showed a wire in the catheter preventing the md from loading the wire onto the catheter.The catheter was removed and replaced with no harm to the patient.This event-1 is being reported based on the wire observed at the hub.
Event or Problem Description
A supplemental report is being submitted to include related medical device report number in section h10.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for analysis however, the investigation is ongoing.The alleged product issue cannot be confirmed at this time.The investigation findings will be included in a supplemental mdr report.
Additional Manufacturer Narrative
The investigation found the returned microcatheter kinked at the distal tip of the hub.Furthermore, an in-house guidewire encountered resistance at the kink during the investigation, which is consistent with the reported resistance.However, the kink was found underneath the strain relief and would not have been seen by the user.The investigation did not find the alleged wire or any other defect inside the hub as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink, but the damage is consistent with the device experiencing forces that exceeded its yield strength.The original guidewire used in the procedure was not returned for evaluation, so the investigation could not determine if it had contributed to the reported complaint.
Event or Problem Description
A supplemental report is being submitted to include the product investigation findings.

• Brand Name: HEADWAY-DUO 16
• 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: 22567353
• Report Number: 2032493-2025-90347
• Device Sequence Number: 18462385
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

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: MC162156S-AL
• Device Lot Number: 0001027774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided; 08/19/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/15/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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: Other
• Patient Sex: Unknown