MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY ADVANCED; MICROCATHETER

Model Number	MC172150SX
Medical Device Problem Codes	Complete Blockage (1094); Peeled/Delaminated (1454); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tech was prepping the headway 17 microcatheter for a stent procedure.While flushing the microcatheter, no liquid was passing through to the distal opening of the microcatheter.They tried multiple syringes with no improvement.They finally replaced the microcatheter with a fresh one and it flushed appropriately.The microcatheter was not placed in the body.Although the initial information received was not determined to be reportable, we are now reporting the event based on device investigation findings of delaminated ptfe liner occluding the lumen.
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.Investigation conclusion: the investigation of the returned headway microcatheter found a flattened section at 9-10cm from the strain relief; furthermore, an in-house guidewire was unable to advance into the hub during functional testing, which is consistent with the alleged product issue.Further inspection found damaged ptfe liner occluding the microcatheter lumen.The physical evaluation of the device could not identify the conditions or circumstances that led to the ptfe liner occlusion, but this condition is consistent with the liner of the lumen experiencing forces exceeding the device's tensile strength.

• Brand Name: HEADWAY ADVANCED
• Common Device Name: MICROCATHETER
• 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: 20888938
• Report Number: 2032493-2024-00885
• Device Sequence Number: 8675938
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)240327(17)270228(10)0000554840
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 0000554840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• 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: 11/15/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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 STENT
• Patient Sex: Unknown