MAUDE Adverse Event Report: MICROVENTION INC. HEADWAY-17 XSUPPORT; ACCESS DEVICES

Model Number	MC172150SX-AL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
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
It was reported that during the stent coil procedure, there was resistance while trying to remove the microcatheter.Upon removal, it was found that the distal tip of the microcatheter was cut off and remained in the patient's body.There was no reported patient injury and the patient was reported to be stable.No additional information was provided.
Additional Manufacturer Narrative
Additional information was received.Updates were made to: b5, d11, g4, h2.
Event or Problem Description
Additional clarifying information received notes that the type of case performed was for a stent coil procedure.The headway microcatheter was placed within the aneurysm, and the stent was placed using another headway microcatheter.After completing the coiling, the doctor tried to remove the microcatheter, but it caught the stent cell and the microcatheter distal tip was torn off.The procedure was finished with the distal tip of the microcatheter remaining in the patient body.There is no plan to address piece remaining in the patient and we will watch the progress of the patient.The device is currently pending receipt.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned headway microcatheter found the distal end stretched and broken, which is consistent with the condition described in the reported event.The distal tip was not returned.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces that exceeded its yield and tensile strengths.
Event or Problem Description
No additional incident information was received; however, the evaluation of the returned device is completed.Please see h6 & h11.

• Brand Name: HEADWAY-17 XSUPPORT
• Common Device Name: ACCESS DEVICES
• 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: 21906174
• Report Number: 2032493-2025-90110
• Device Sequence Number: 18298412
• Product Code: DQY
• UDI-Device Identifier: 00842429117439
• UDI-Public: (01)00842429117439(11)240521(17)270430(10)0000605819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101542
• 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,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC172150SX-AL
• Device Lot Number: 0000605819
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 06/12/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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, PT NO. UNKN, LOT NO. UNKN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 63 KG