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

Model Number	MC212156S-AL
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was being used with a flow diverter stent in an unspecified procedure.After the first flow diverter stent was implanted, a second stent with the same microcatheter should be implanted.However, the physician noticed that the inner coating of the headway had come loose.The microcatheter was replaced and a new microcatheter was used and the operation was successfully completed.The patient did not suffer any damage and was reported to be doing well.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
A non-reportable report is being submitted based on the returned product investigation findings.The ptfe lining of the microcatheter lumen was found to be intact and no damage was observed to the microcatheter coating.Based on the investigation findings, this event no longer meets the mdr reportable criteria.Additional information from the physician indicated when the advancement difficulty with the guidewire was encountered, it was suspected that the coating may have detached.However, this was indicated to be an assumption, the cause of the advancement difficultly was not known.Please see h6 & h11.
Additional Manufacturer Narrative
Correction to h6: adverse event problem.H6, medical device problem code, remove 1454, peeled/delaminated.H6, medical device problem code, add 2920, difficult to advance.Based on additional incident clarification received and the device evaluation findings, a final non-reportable report is being submitted.Information from the physician indicated when the advancement difficulty with the guidewire was encountered, it was suspected that the coating may have detached.However, this was indicated to be an assumption, the cause of the advancement difficultly was not known.The investigation found that the returned pusher was able to be pushed out of the returned headway microcatheter without resistance.The ptfe lining of the microcatheter lumen was found to be intact and no damage was observed to the microcatheter coating.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.Additionally, there was no reported adverse patient consequence that occurred.Based on the investigation findings, this event no longer meets the mdr reportable criteria.

• Brand Name: HEADWAY 21+
• 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: 22586622
• Report Number: 2032493-2025-90355
• Device Sequence Number: 11887620
• Product Code: DQY
• UDI-Device Identifier: 00842429117484
• UDI-Public: (01)00842429117484(11)240920(17)270831(10)0000706604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: MC212156S-AL
• Device Lot Number: 0000706604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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: PHENOX P64 FLOW DIVERTER (WALLABY MEDICAL).
• Patient Sex: Unknown