MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS-14; 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	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation findings: 1.Visual and magnifying inspections of the actual sample.No fracture was found along the entire length of the actual sample.No anomaly in the appearance was found in the area 0- approx.1000mm from the distal end and at the proximal end.The shaft had been curved approximately 1,285mm from the distal end.No cracks or the like were found in the curved part.Peeling of ptfe coat was found at approx.1,946mm from the distal end.No anomaly was found in other parts.From the above, it was speculated that the reported nick referred to the peeling of the ptfe coating.The curve was presumably caused by some kind of bending load and was considered unlikely to be related to this complaint.Investigation conclusion: based on the investigation result, no anomaly was found in the dimensions of the actual sample.Based on the condition of the actual sample and the results of the simulation test, as one of the possibilities, it was inferred that a hard object had come into contact with the surface of the shaft section, causing an abrasive load to be applied, resulting in the peeling of the ptfe coating.However, because the details of the procedure were unknown, it was not possible to identify such a hard object from the condition of the actual sample.
Event or Problem Description
It was reported that the guidewire was used in mechanical thrombectomy procedure.During preparation and upon removing the guidewire from the plastic sheath, it was noted that the guidewire is nicked.There was no patient involvement and guidewire was not used and was returned back into the sheath.After the procedure the patient was recovering, lifting the limbs in antigravitational test.There was no report of harm or injury to the patient; 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-14
• 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: 19620061
• Report Number: 2032493-2024-00499
• Device Sequence Number: 8205124
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)000101(17)260531(10)230628
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 230628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• 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: 06/11/2024
• Initial Report FDA Received Date: 06/26/2024
• 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: 86 YR
• Patient Sex: Female