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

Model Number	MC162156S
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.
Event or Problem Description
As reported: headway duo 156cm was being used in a facial avm treatment, around the facial artery, so not intracranial.The headway duo performed as expected for about 15 minutes of the case.The liquid embolic was being used and everything was fine until the end of the case and finished embolizing.As the headway duo was being pulled back, they noticed a great deal of resistance, holding the headway duo in.The guide catheter and the intermediate catheter were advanced as they pulled the headway duo, but the headway duo broke, leaving the distal 15mm lodged in the artery.Assessing the situation, they decided to push the detached tip of the headway duo into the facial artery where they were satisfied it would stay.The patient was discharged the same day without issue.No harm to the patient.No blood loss.No device to return.

• 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: 21896323
• Report Number: 2032493-2025-90101
• Device Sequence Number: 11623716
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)240826(17)270731(10)0000686591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC162156S
• Device Lot Number: 0000686591
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BENCHMARK BMX81 GUIDE CATHETER.; PENUMBRA MID INTERMEDIATE CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown