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

Model Number	MC162156S-AL
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances 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.A portion of the device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If a portion of the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the physician used glue (nbca) to embolize the vessel through the microcatheter.When they attempted to remove the microcatheter, the glue polymerize and hardened quickly around the catheter, leaving it stuck.Upon trying to remove it, the catheter remained stuck.The catheter was pulled with force, and then it broke.It appears that a portion of the broken catheter that came off got stuck in the glue.The other portion of the catheter was removed from the patient.The patient is in stable condition.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
The investigation found the microcatheter returned with a substance within the hub that appeared consistent with solidified liquid embolic material.The distal tip was found stretched and broken with the lumen coil pulled out, which is consistent with the condition described in the reported event.The segment distal to the break was not returned for evaluation.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the damage, but the damage is consistent with the distal tip of the microcatheter becoming encased in solidified liquid embolic followed by retraction forces that exceeded the device's tensile strength.

• 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: 22801266
• Report Number: 2032493-2025-90403
• Device Sequence Number: 8805265
• Product Code: DQY
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)250626(17)280531(10)0001149785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MC162156S-AL
• Device Lot Number: 0001149785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown