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

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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the investigation found that an in-house guidewire was unable to be advanced into the lumen of the returned headway microcatheter, which is consistent with the alleged product issue.Further investigation found the lumen to not be fully flared at the hub joint, an exposed braid protruding into the lumen, and delaminated ptfe in the lumen, which would have caused or contributed to the guidewire advancement issue.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the lumen flaring issue, exposed braid, and delaminated ptfe, but these conditions are consistent with a deviation in the manufacturing process and is being addressed per the quality process.A capa has been initiated.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.
Event or Problem Description
It was reported that the concerned microcatheter was being used in an mma embolization procedure.Reportedly, while prepping the microcatheter, a 0.014 wire attempted to inserted into the microcatheter but the wire would not advance through the hub of the microcatheter.The physician decided to use a new microcatheter of the same model, which performed as designed successfully.There was no report of injury to the patient.The investigation of the returned device found exposed coil protruding into the lumen at the hub transition.

• Brand Name: HEADWAY-DUO 16
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 24327410
• Report Number: 2032493-2026-00088
• Device Sequence Number: 21188087
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: 00842429117408
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 0001147950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• 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: 02/09/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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
• Patient Sex: Unknown