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	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the investigation found that the returned coils encountered resistance when attempting to advance 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 not be fully flared at the hub joint with the lumen coil exposed and the ptfe lining damaged, which would have resulted in the resistance encountered.The exposed coil was observed to be protruding into the lumen.The physical evaluation of the microcatheter could not identify the exact conditions or circumstances that led to the exposed coil, damaged ptfe lining, and lumen flaring issue, but these conditions are consistent with a deviation in the manufacturing process.Two of the four returned coils were found kinked at the pusher, which may have contributed to the advancement issue.The physical evaluation of the coils could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces exceeding the pusher's yield strength.A search for non-conformance's 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.
Event or Problem Description
It was reported that the concerned microcatheter was used in an unspecified coil embolization procedure.Reportedly, the coils would not advance in the microcatheter.Some different coils' brands were used and some were delivered; others could not advance in the microcatheter.Eventually a wire was not able to be advanced thru the catheter.There was no report of injury to the patient.The investigation of the returned device found exposed coil protruding into the lumen at the hub transition.

• 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: 23897970
• Report Number: 2032493-2025-90742
• Device Sequence Number: 18739066
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: 00842429117408
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 12/26/2025

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: 0001147948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• 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: 12/16/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: EMBOLIZATION COILS (UNKNOW MODEL) (MEDTRONIC).
• Patient Sex: Unknown