MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+ MICROCATHETER; CATHETER, PERCUTANEOUS

Model Number	MC212156S
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Investigation conclusion: the investigation of the returned microcatheter found the inner lining damaged at the proximal end with exposed braid; furthermore, an in-house guidewire encountered resistance during insertion, which is consistent with the reported resistance.The physical evaluation of the device could not identify the conditions or circumstances that led to the damaged lining, but this condition is consistent with attempting to insert another device into the defective microcatheter.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed braid, but this condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.
Event or Problem Description
As reported: the physician was treating a fusiform aneurysm on the left vertebral artery.The implantation of a silk flowdiverter was planned.A headway 21 was chosen for the procedure.It was not possible to advance the silk (3,5-15) into the headway 21.The headway 21 was exchanged and the same silk was used.The examination continued with good results.The patient is doing well.No injury caused by this issue.No other incident information was received.When the device was received for evaluation, the investigation findings found an exposed lumen coil.

• Brand Name: HEADWAY 21+ MICROCATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 23636885
• Report Number: 2032493-2025-90672
• Device Sequence Number: 21077091
• Product Code: DQY
• UDI-Device Identifier: 00812636020945
• UDI-Public: (01)00812636020945(11)240124(17)261231(10)0000502449
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093160
• 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
• Report Date (Section B): 11/24/2025

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: MC212156S
• Device Lot Number: 0000502449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• 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: 11/10/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SILK (3,5-15) FLOWDIVERTER UNKNOWN DETAILS.
• Patient Age: 62 YR
• Patient Sex: Female