MAUDE Adverse Event Report: MICROVENTION INC. HEADWAY; 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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a headway duo microcatheter would not accept a guidewire.A new catheter was selected and the guidewire worked with it.The device had no patient contact.When the device was received for evaluation, the investigation findings found the lumen to not be fully flared at the hub joint with exposed braid in the lumen, and delaminated ptfe was in the lumen.
Additional Manufacturer Narrative
The investigation found that an in-house guidewire was able to advance into the lumen of the returned headway microcatheter without encountering friction or resistance.However, upon further investigation, the lumen was found to not be fully flared at the hub joint, an exposed braid was observed in the lumen, and delaminated ptfe was 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 will be addressed per the quality system 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.

• Brand Name: HEADWAY
• 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: 22057847
• Report Number: 2032493-2025-90167
• Device Sequence Number: 8394228
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: 00842429117408
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/20/2025

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 Catalogue Number: MC162156S
• Device Lot Number: 0000808727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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