MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS GUIDEWIRE; GUIDE, WIRE, 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	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned traxcess guidewire found delaminated pieces of ptfe coating present in the area 625mm to 812mm from the distal end and 1067mm to 1330mm from the distal end.However, no stretching/distension was observed throughout the length of the device as described in the reported event and therefore, this complaint is considered unconfirmed.A traxcess sample was inserted into an attached metal inserter during simulation testing, and the shaft of the traxcess was brought into contact with the edge of the metal inserter tip.The traxcess in that state was then bent and pulled out so as to be exposed to an abrasion load.As a result, delamination of ptfe coating occurred on the shaft section.Therefore, it was inferred that a hard object (e.G., metal object) came into contact and abraded the surface of the shaft section, which resulted in the delamination of the returned device's ptfe coating.However, it was not possible to identify the hard object from the condition of the actual sample.
Event or Problem Description
It was reported that during the cerebral embolization procedure, the device presented stretching/distension in its wire, making it impossible to use, and was replaced by another.Procedure completed successfully without any complications or problems with the patient.Patient outcome was described as "great." there was no report of harm or injury to the patient as the issue was noticed during prepping.However, upon evaluation of the returned guidewire, peeling of the ptfe coating at the distal end was noted.(refer to section h11 for device evaluation).

• Brand Name: TRAXCESS GUIDEWIRE
• Common Device Name: GUIDE, WIRE, 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: 19669044
• Report Number: 2032493-2024-00515
• Device Sequence Number: 3136843
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)000101(17)260531(10)230612
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080863
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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 Expiration Date: 05/31/2026
• Device Model Number: GW1420040
• Device Lot Number: 230612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• 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: 06/19/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2000
• 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: 72 YR
• Patient Sex: Female