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

Model Number	MC172150SX-AL
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that an in-house guidewire could not be fully advanced through the returned microcatheter, which is consistent with the alleged product issue.A clear material consistent with ptfe was found compacted and occluding the distal end of the microcatheter.Further investigation found exposed coil and damaged/missing ptfe lining at the hub transition, which would have contributed to the resistance encountered during the investigation.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed coil, but this condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.The ptfe damage/delamination and resulting occlusion are consistent with advancing another device through the microcatheter with exposed coil.
Event or Problem Description
It was reported that the guide wire did not pass smoothly through the microcatheter.A new catheter was used to complete the case.The patient is in stable condition.Additional information was received from the post evaluation report revealed an exposed coil and damaged/missing ptfe lining at the hub transition, which would have contributed to the resistance encountered during the investigation.The ptfe damage/delamination and resulting occlusion are consistent with advancing another device through the microcatheter with exposed coil.

• 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: 23717878
• Report Number: 2032493-2025-90686
• Device Sequence Number: 15678763
• Product Code: DQY
• UDI-Device Identifier: 00842429117439
• UDI-Public: (01)00842429117439(11)250624(17)280531(10)0001146720
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/04/2025

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-AL
• Device Lot Number: 0001146720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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
• Patient Sex: Unknown