MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-17 XSUPPORT; PERCUTANEOUS CATHETER

Model Number	MC172150SX
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that an in-house guidewire encountered friction when advanced into the lumen of the returned headway microcatheter, which is consistent with the alleged product issue.Further investigation found the lumen to not be fully flared at the hub joint.Exposed braiding and delaminated ptfe in the lumen were also found, which is likely related to the incomplete flaring.A kink under the strain relief was also identified.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink, but the kink is consistent with the device experiencing forces exceeding the device's yield strength.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the lumen flaring issue, but this condition is consistent with a deviation in the manufacturing process that is being addressed through the quality system process and a capa has been initiated.
Event or Problem Description
During the procedure, the operator reported that the catheter had a ¿wrong/bad lumen - resistance was felt, the coil could not be delivered¿.There was no patient injury nor intervention.This complaint was originally assessed as non-reportable.However, based on the product evaluation findings, a vigilance report is being conservatively submitted based on the investigation findings of exposed braid within the microcatheter lumen.

• Brand Name: HEADWAY-17 XSUPPORT
• Common Device Name: PERCUTANEOUS CATHETER
• 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: 22007399
• Report Number: 2032493-2025-90152
• Device Sequence Number: 5404610
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)240530(17)270430(10)0000613767
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K083343
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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 Expiration Date: 04/30/2025
• Device Model Number: MC172150SX
• Device Lot Number: 0000613767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• 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: 05/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: COIL.
• Patient Sex: Unknown