MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC212156S-AL
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found the returned microcatheter to exhibit delaminated ptfe lining, exposed braid and a lumen coil protruding into the lumen at the hub transition, which would have caused the resistance described in the reported event.The stent pusher was returned with the warning marks damaged, which is consistent with the customer provided image.The damage to the warning marks is consistent with the pusher getting caught on the protruding coil during advancement.The physical evaluation of the device could not identify the conditions or circumstances that led to the exposed braid, but this conditions is consistent with a deviation in the manufacturing process.The ptfe damage is consistent with attempting to advance another device into the microcatheter with the exposed braid/lumen coil.
Event or Problem Description
It was reported when treating a aci aneurysm, a fredx should be used.The xfred could not be completely pushed through the headway21.Upon closer inspection, it was noticed that there was a foreign object on the pusher wire.To successfully finish the intervention, another headway21 with the same and another xfred2513 were taken.No injury to the patient.When the device was received for evaluation, the investigation findings found an exposed braid.

• Brand Name: HEADWAY 21+
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 24310020
• Report Number: 2032493-2026-00076
• Device Sequence Number: 21252527
• Product Code: DQO
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484(11)250224(17)280131(10)0001011800
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120917
• 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): 02/09/2026

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-AL
• Device Lot Number: 0001011800
• Was Device Available for Evaluation?: Yes
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown