MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+; 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	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned device found exposed braid and damaged/delaminated ptfe at the hub transition; furthermore, an in-house stent could not be inserted into the microcatheter, which is consistent with the alleged product issue.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.The damaged ptfe lining is consistent with attempting to advance a stent into the microcatheter with exposed braid.
Event or Problem Description
As reported: used a headway21 and attempted to deliver a competitor flow diverter with it, but unfortunately it didn¿t work.According to both packages, they should have been compatible.The competitor flow diverter could not be pushed through the headway21.The physician noticed strong friction when pushing it forward.For case completion, they used a different microcatheter to implant the competitor flow diverter, and this went smoothly without any complications.Patient is doing fine! when the device was received for evaluation, the investigation findings found an exposed braid at the hub transition.

• Brand Name: HEADWAY 21+
• 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: 23825610
• Report Number: 2032493-2025-90717
• Device Sequence Number: 9030421
• Product Code: DQY
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484(11)240701(17)270630(10)0000641350
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 0000641350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: BALT SILK VISTA FLOW DIVERTER.
• Patient Sex: Unknown