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

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	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation of the device, two microcatheters would not accept a guidewire through both units.The wire was getting stuck around the hub section and would not advance.The microcatheter was not used and a new microcatheter with a different lot number was used to continue the procedure.When the device was received and analyzed; it was found that the catheter shaft exhibited incomplete flaring with exposed braid at the hub transition.The device associated with this report was used during the same procedure referenced in mfr.Report# 2032493-2025-90089.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned microcatheter found no damage on the surface of the device; however, an in-house guidewire could not be advanced past the hub during functional testing, which is consistent with the alleged product issue.The proximal microcatheter shaft exhibited incomplete flaring with exposed braid and delamination at the hub transition, which would have contributed to the resistance experienced during the investigation.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the flaring issue, but this condition is consistent with a deviation in the manufacturing process.The physical evaluation of the device could not identify the conditions or circumstances that led to the delamination, but this condition is consistent with attempting to insert an ancillary device into the insufficiently flared lumen.The catheter condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.

• Brand Name: HEADWAY-DUO 16
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21870431
• Report Number: 2032493-2025-90090
• Device Sequence Number: 8742660
• Product Code: DQY
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)241030(17)270930(10)0000751583
• 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): 04/21/2025

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: 0000751583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• 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: 04/18/2025
• Initial Report FDA Received Date: 04/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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