MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS 14EX GUIDEWIRE (14 IN.); CATHETER, GUIDE WIRE

Model Number	GW1420040X
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after hydrating the traxcess, the guidewire was inserted into the microcatheter from the y-valve, which encountered resistance and was difficult to push.The physician replaced the microcatheter; however, the attempt failed.The guidewire was replaced, which was reported to have been very smooth.The patient was reported to be doing fine.
Additional Manufacturer Narrative
The manufacturing record and the shipping inspection record of the involved product code/lot number: no anomaly was found.The initial complaint reported resistance in the microcatheter, which is not a reportable event; however, the investigation results found the hydrophilic coating was peeled, which is a reportable malfunction.As a result, mvi will report for the peeled coating issue found in the device investigation.The visual inspection of the returned guidewire found peeled hydrophilic coat on the coil surface.Replication testing using a factory-retained headway17 found the guidewire was able to successfully advance through the lumen without issue; therefore, the investigation determined the peeled hydrophilic coat on the coil surface is likely not related to the initial resistance noted in the complaint description.The investigation determined that another contributing factor (unknown to the investigation of the guidewire alone) likely resulted in the initial friction and subsequent damage to the guidewire surface.Without the return and evaluation of the associated devices used in the procedure, the investigation cannot determine the original cause for the reported event.

• Brand Name: TRAXCESS 14EX GUIDEWIRE (14 IN.)
• Common Device Name: CATHETER, GUIDE WIRE
• 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: 17293944
• Report Number: 2032493-2023-00835
• Device Sequence Number: 20376997
• Product Code: MOF
• UDI-Device Identifier: 00810170014864
• UDI-Public: (01)00810170014864(11)220526(17)250430(10)220526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: 04/30/2025
• Device Model Number: GW1420040X
• Device Catalogue Number: GW1420040X
• Device Lot Number: 220526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• 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: 06/15/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG