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

Model Number	GW1420040
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: web procedure, after establishing the pathway, guidewire with via to the m2 in the brain, carried out superselection into the aneurysm, after several times without success, ready to remove and remodel.After the removed, the physician found that the clean water coating on the surface of the guide wire fell and replaced it with a new one.The procedure ended and the patient was safely.Patient is fine.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The reported 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.
Additional Manufacturer Narrative
Section b5: additional information received.Section h6 (type of investigation): code has been corrected from "device discarded" to "device not returned".The device is in transit to be returned to the manufacturer for evaluation but has not yet been received by the manufacturer.The reported 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
As reported: during the web procedure, after establishing the pathway, guidewire with via to the m2 in the brain, superselection was carried out into the aneurysm.After several times without success, the physician was ready to remove and remodel.After removal, the physician found that the clean water coating on the surface on the guidewire fell and replaced with it with a new one.The procedure ended and the patient was safe.Additional information received: when the doctor took out the micro-guidewire outside the patient's body and reshaped it, he found that the coating fell (to his finger).The physician confirmed that no fallen coating was in the patient's body.
Additional Manufacturer Narrative
Two guidewire samples were received.However, it was confirmed that both samples were manufactured by a different company.Since the actual sample was not available for return, investigation of the reported device could not be performed.In the manufacturing process, the following operations and inspections are performed to maintain the quality: 1) following the application of the outer layer to the shaft, a magnifying inspection is carried out on 100% of the products to ensure that there are no anomalies in the appearance, such as peeling of the outer layer.2) during the shipping inspection, a magnifying inspection is conducted on a per-lot basis to ensure that there are no anomalies in the appearance, such as peeling of the outer layer.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.There are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Based on the investigation result, since no non-conformance was found in the manufacturing history records and the actual sample was not returned, the cause of the reported event could not be determined.
Event or Problem Description
As reported: during the web procedure, after establishing the pathway, guidewire with via to the m2 in the brain, superselection was carried out into the aneurysm.After several times without success, the physician was ready to remove and remodel.After removal, the physician found that the clean water coating on the surface on the guidewire fell and replaced with it with a new one.The procedure ended and the patient was safe.Additional information received: when the doctor took out the micro-guidewire outside the patient's body and reshaped it, he found that the coating fell (to his finger).The physician confirmed that no fallen coating was in the patient's body.

• 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: 19086941
• Report Number: 2032493-2024-00286
• Device Sequence Number: 15229621
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)231019(17)260930(10)231019
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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: 09/30/2026
• Device Model Number: GW1420040
• Device Lot Number: 231019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided; 07/10/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/06/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIA MICROCATHETER.
• Patient Sex: Unknown