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

Model Number GW1420040

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 339897047
• Report Number: 2032493-2024-00286
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)231019(17)260930(10)231019
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GW1420040
• Device Lot Number: 231019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1