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

Model Number	MC162156S-AL
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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
As reported: final coil implanted (optima helical 1.5x2 - is a -10 coil), felt a snag when removing delivery wire.When delivery wire removed some metal present in micro catheter hub plus proximal end of microcatheter.Under magnification has a coiled appearance however the actual coil used was implanted and detached successfully.Could be part of the microcatheter reinforcement wind or part of the coil delivery system? the patient was reported to be "well".
Additional Manufacturer Narrative
The investigation of the returned microcatheter found kinks at the distal end and a coil detached in the hub, which is consistent with the alleged product issue.However, the coil retrieved from the hub was found to be the distal end of a broken coil implant--not part of the microcatheter.An in-house coil system was inserted into the returned microcatheter but could not be advanced past the kinks, which is consistent with the reported resistance.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 exceeding its yield strength.
Event or Problem Description
No new information was reported.

• Brand Name: HEADWAY
• 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: 23764836
• Report Number: 2032493-2025-90697
• Device Sequence Number: 13183459
• Product Code: DQO
• UDI-Device Identifier: 00842429117408
• UDI-Public: (01)00842429117408(11)250813(17)280731(10)0001220115
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 0001220115
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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: OPTIMA HELICAL 1.5X2.
• Patient Sex: Unknown