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

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	02/02/2025
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.The investigation of the returned headway microcatheter found that an in-house guidewire encountered resistance when advanced into the lumen of the returned headway microcatheter during functional testing, which is consistent with the advancement issue described in the reported event.The lumen of the microcatheter was found to have damaged ptfe liner and an exposed braid, which would have resulted in the resistance encountered.The physical evaluation of the device could not identify the conditions or circumstances that led to the damaged ptfe liner and exposed braid, but these conditions are consistent with consistent with a deviation in the manufacturing process.A capa has been initiated.
Event or Problem Description
It was reported that the wire would not pass the hub.There was no patient injury nor surgical intervention reported.The patient is in good condition.Although the initial information received was not determined to be reportable, we are now reporting the event based on device investigation findings of the microcatheter lumen was found to have damaged ptfe liner and an exposed braid.

• Brand Name: HEADWAY-DUO 16
• Common Device Name: CATHETER PRECUTANEOUS
• 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: 22128552
• Report Number: 2032493-2025-90215
• Device Sequence Number: 15578432
• Product Code: DQY
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)240203(17)270131(10)0000512984
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/02/2025

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
• Device Lot Number: 0000512984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2024
• 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 Age: 70 YR
• Patient Sex: Female