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

Model Number	MC162156S-AL
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	07/17/2025
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.The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The alleged product issue could not be confirmed.If 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, during a csdh embolization procedure with the use of onyx and a headway duo microcatheter, the tip of one of the microcatheters broke off inside the patient.The microcatheter became embedded in the onyx cast less than 4 minutes after the start of the embolization, with the embolic agent surrounding it distally for a maximum of 3 minutes, that approximately 10-15 cm of the tip broke off during removal and remained in the middle meningeal artery.Clinically, the intravascular remnant in this location currently has no consequences for us.There was no reported injury or intervention and it had no influence to the patients outcome.
Additional Manufacturer Narrative
H11.Please note this mdr was originally submitted in error as only a product problem.B1, b2, and h1 were corrected to reflect serious injury as incident details indicate / determine that the catheter is not meant to be implanted in the patient.All other previously submitted data remains correct.
Event or Problem Description
This supplemental report is being submitted to only correct information in sections: b1, b2 and h1.Please see h2, h11.
Event or Problem Description
Supplemental report is being submitted to only correct information in sections: b1, b2 and h1.Please see h2, h11.
Additional Manufacturer Narrative
H11: please note this mdr was originally submitted in error as only a product problem.B1, b2 and h1 were corrected to reflect serious injury as incident details indicate/determine that the catheter is not meant to be implanted in the patient.All other previously submitted data remains correct.
Additional Manufacturer Narrative
Investigation conclusion: one radiographic image and photos of the device and packaging label were provided for review.The radiographic image shows an onyx cast with the broken microcatheter segment trapped inside it, which is consistent with the alleged product issue.The investigation found the microcatheter returned with residual onyx inside the hub.The shaft was found kinked at 65.0cm and 65.8cm from the strain relief and stretched, flattened, and broken at the distal tip, which is consistent with the customer-provided device image.The segment distal to the break was not returned.The physical evaluation of the device could not identify the conditions or circumstances that led to the kinks, but the damage is consistent with the device experiencing forces that exceeded its yield strength.The physical evaluation of the device could not identify the conditions or circumstances that led to the distal tip damage, but the damage is consistent with the microcatheter tip becoming encased in solidified liquid embolic and experiencing retraction forces that exceeded its tensile strength.
Event or Problem Description
No additional information was received; however the evaluation of the returned device is completed.Please see h6 & h11.

• 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: 22734253
• Report Number: 2032493-2025-90377
• Device Sequence Number: 9104299
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)250508(17)280430(10)0001080163
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2025

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-AL
• Device Lot Number: 0001080163
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 10/03/2025; 10/03/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/08/2025; 10/08/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: ONYX 18
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male