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

Model Number	MC162167S-AL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: operator broke catheter in mma by leaving it in too long with the liquid embolic.The catheter was left too long in the liquid embolic and became stuck, so when they removed it the catheter tip broke off forcefully and some was retained in the liquid embolic.Case was completed.Patient is fine.
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.The device has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation found the headway microcatheter returned kinked at 38cm from the strain relief and with residual liquid embolic material in the hub and distal lumen.The distal tip was found stretched, kinked, and broken with the lumen coil pulled out, which is consistent with the condition described in the reported event.The microcatheter 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.
Event or Problem Description
No additional information received regarding the event.

• 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: 22974260
• Report Number: 2032493-2025-90461
• Device Sequence Number: 9370732
• Product Code: DQY
• UDI-Device Identifier: 00842429117415
• UDI-Public: (01)00842429117415(11)250522(17)280430(10)0001103937
• 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): 10/29/2025

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: MC162167S-AL
• Device Lot Number: 0001103937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: CERENOVUS NBCA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown