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

Model Number	MC162156S-AL
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation; however, it has not yet been returned.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported, the headway duo catheter was introduced into the support catheter and the.014 aristotle wire which had previously gone through the headway duo catheter with no issues wouldn't advance through the headway duo catheter.Catheter and wire were removed from the patient and hep saline was flushed through the duo with much difficulty, and when the hep saline finally came out a small piece of something white flushed out with it.We were unable to retain the white object as it was extremely small and got lost while attempting to retain it.It was outside of the patient at that time.The device will be returned for analysis.The patient outcome is reported as "good".

• 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: 21665677
• Report Number: 2032493-2025-00242
• Device Sequence Number: 7755881
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)250110(17)271231(10)0000868398
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: 0000868398
• Was Device Available for Evaluation?: Yes
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 ARISTOTLE WIRE.
• Patient Sex: Unknown