MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS-14; ACCESS DEVICES

Model Number	GW1420040
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the case was being performed by 2 experienced interventionists.The traxcess wire was used to deliver a microcatheter into the m2 segment of the middle cerebral artery.The catheter was placed and the microwire was removed.When the operator tried to place the stent into the microcatheter there was significant resistance, and the stent was unable to be tracked forward to the catheter tip.The users then investigated the devices that they had been using and identified some irregularities along the length of the traxcess wire, which they identified as stripping of the hydrophilic coating.An assumption was made that parts of this coating were lodged in the microcatheter impeding the delivery of the stent.A secondary wire (stryker synchro select) was used to re cannulate and a new microcatheter and stent was used to successfully to complete the case.No reported injury to the patient.
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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Based on the investigation results, no anomalies were found in the manufacturing history records and in the dimensions.On the other hand, there was slight resistance in hand sensory confirmation of lubricity, and dyeing confirmation showed peeling of the hydrophilic coat.However, since the concomitant device was not returned and the details of the procedure were unknown, the cause of the occurrence could not be clarified.The hydrophilic coat is controlled by the assurance system, which ensures that the hydrophilic coat is applied.Therefore, it was considered that the peeling of the hydrophilic coat was caused by some kind of abrasion force.The peeling of the ptfe coat observed on the actual device was considered to have been caused by strong contact with some hard object.However, since the details of the procedure were unknown, the cause of the occurrence could not be clarified for the peeling of the hydrophilic coat and the ptfe coat.
Event or Problem Description
H11.

• Brand Name: TRAXCESS-14
• 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: 21869637
• Report Number: 2032493-2025-90088
• Device Sequence Number: 12741721
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)230111(17)251231(10)230111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110813
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Expiration Date: 12/31/2025
• Device Model Number: GW1420040
• Device Lot Number: 230111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: Female