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	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the investigation found that an in-house guidewire was unable to advance through the returned microcatheter during functional testing.Further investigation found delamination and exposed braid at the hub join, which would have contributed to the reported resistance.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the delamination and exposed braid, but these conditions are consistent with insufficient fusing of the catheter lumen during manufacturing.The catheter condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.
Event or Problem Description
It was reported that the wire would not go through catheter and had to open new catheter.The device was received for evaluation, the investigation findings found delamination and exposed lumen braid at the hub joint of the microcatheter.Therefore, the complaint is being reported.

• 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: 22200216
• Report Number: 2032493-2025-90254
• Device Sequence Number: 15124032
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)240906(17)270831(10)0000697117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/12/2025

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: 0000697117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• 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: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• 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: Male