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

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	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: a headway 17 was used for a coiling.The wires were very difficult to push through the headway and the headway folded up at the tip when the coil was pulled back.Patient is doing fine.When the device was received for evaluation, the investigation findings found an exposed lumen coil.
Additional Manufacturer Narrative
The investigation found the returned guidewire with strands of ptfe liner from the microcatheter lumen on the distal end.The returned microcatheter was found flattened at 6cm from the strain relief.The guidewire could not advance into the returned headway microcatheter during functional testing, which is consistent with the alleged product issue.The lumen of the microcatheter was found to have delaminated ptfe with the lumen braid exposed, which would have resulted in the resistance encountered.The physical evaluation of the device could not identify the conditions or circumstances that led to the flattened shaft, but this damage 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 delaminated ptfe liner and the exposed lumen coil, but these conditions are consistent with a deviation in the manufacturing process and will be addressed per the quality system process.A capa has been initiated.This event is being reported due to the finding of the exposed lumen braid out of an abundance of caution, as it is deemed that should the event recur, it could potentially cause injury.

• Brand Name: HEADWAY-17 XSUPPORT
• 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: 22745290
• Report Number: 2032493-2025-90385
• Device Sequence Number: 7534231
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)240216(17)270131(10)0000521387
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101542
• 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): 08/07/2025

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: MC172150SX
• Device Lot Number: 0000521387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: STRYKER SYNCHRO SELECT
• Patient Sex: Unknown