MAUDE Adverse Event Report: MICROVENTION INC. TRAXCESS-14; WIRE GUIDE CATHETER

Model Number	GW1420040
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 device preparation prior to use, the nurse prepared and tested the guidewire by inserting it into the introducer and found that some parts had come loose.So, the guidewire had to be replaced.It was suspected that the micro guidewire coating was damaged.There was no patient involvement.
Event or Problem Description
No additional information was received, please see h6 & h11.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned guidewire kinks in multiple sections at the distal end, the coil jumbled at 36mm from the distal end, and the ptfe coating intermittently peeled off from 714mm from the distal end to the rear end, which is consistent with the condition observed in the customer provided image and video.Based on the investigation result, no anomaly was found in the manufacturing history record and dimensions at the normal sections.From the condition of actual device, provided video, and simulation test result, it was likely that since the actual device was bent and pressed against the metal device to firmly abraded, it was kinked and ptfe coating was peeled off.Regarding the cause of jumbling in the coil, it was inferred that torque force was applied.However, since the details of procedure were unknown, it was not possible to clarify exactly when the event occurred.

• Brand Name: TRAXCESS-14
• Common Device Name: WIRE GUIDE CATHETER
• 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: 21708254
• Report Number: 2032493-2025-90008
• Device Sequence Number: 21350156
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)240703(17)270630(10)240703
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080863
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: GW1420040
• Device Lot Number: 240703
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 62 KG