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

Model Number	MC172150S
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found the microcatheter returned with a stent detached in the hub, which is consistent with the condition described in the reported event.The microcatheter was found to have an exposed coil protruding into the lumen, which would have caused the reported resistance and resulting detachment as the stent was attempted to be advanced and resheathed.The stent pusher was returned intact; however, the distal marker band detached during the investigation.The stent was loaded onto an in-house pusher with the returned introducer and advanced through an in-house microcatheter without resistance or premature detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed lumen coil, 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: patient was to be treated for a ruptured acom aneurysm with stent assisted coiling.Headway 17 was parked across the acom in the sac.The first coil selected deployed in the sac without detaching it.Stent was selected, prepared as per the ifu and introduced into the microcatheter hub.While transferring the stent to the microcatheter, the physician felt resistance, but when he saw that stent was going inside the catheter, he continued pushing it.But after a couple of mm, the stent got stuck and was not moving to and fro.Physician did apply a lot of pressure and maneuvers, but the stent did not move.During these maneuvers, the introducer sheath jumped backward and the stent got completely exposed in the microcatheter hub.Looking at this, physician took out the complete assembly, including headway 17 and stent, and kept it aside.Completed the case with a new headway 17 and stent.Patient was extubated & discharged after five days.When the device was received for evaluation, the investigation findings found an exposed lumen coil protruding into the lumen.

• Brand Name: HEADWAY-17 REGULAR
• 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: 23504020
• Report Number: 2032493-2025-90642
• Device Sequence Number: 12987871
• Product Code: DQY
• UDI-Device Identifier: 00810170013744
• UDI-Public: (01)00810170013744(11)241014(17)270930(10)0000728215
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: MC172150S
• Device Lot Number: 0000728215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: LVIS EVO (MODEL LEV2512).
• Patient Age: 42 YR
• Patient Sex: Male