BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PV-TRACKER GUIDE WIRE

    MDR report key: 23656414 · Received November 26, 2025

    Report

    Report Number
    2182208-2025-10571
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 20, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    UDI-DI
    00643169530539
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PSCC100 PRODUCT TYPE: CATHETER MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 990045 GUIDEWIRE WITH LOT NUMBER 8831924 WAS RETURNED AND ANALYZED. THE GUIDEWIRE WAS RECEIVED, EXTENDED BEYOND THE DISTAL TIP OF THE CATHETER ABOUT 3 INCHES. VISUAL INSPECTION OF THE GUIDEWIRE EXTERNAL TO THE CATHETER REVEALED A FOREIGN MATERIAL (VISUALLY IDENTIFIED AS HUMAN TISSUE) STUCK ON THE GUIDEWIRE AT THE CATHETER TIP OPENING. THE GUIDEWIRE WAS STUCK WITHIN THE CATHETER'S GUIDEWIRE LUMEN AND COULD NOT BE MOVED. AFTER REMOVING A PIECE OF FOREIGN MATERIAL THAT WAS WRAPPED AROUND THE GUIDEWIRE, IT WAS ABLE TO PASS THROUGH THE LAB TEST CATHETER WITHOUT RESTRICTION OR EXCESSIVE FRICTION. IN CONCLUSION, THE REPORTED ISSUES (GUIDEWIRE STUCK IN THE GUIDEWIRE LUMEN OF THE CATHETER, GUIDEWIRE COULD NOT BE ADVANCED OR PULLED BACK, TISSUE) WERE CONFIRMED THROUGH TESTING. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE PV TRACKER GUIDEWIRE BECAME STUCK IN THE GUIDEWIRE LUMEN OF THE CATHETER DURING ABLATION. THE GUIDEWIRE COULD NOT BE ADVANCED OR PULLED BACK, AND THE ENTIRE SYSTEM WAS WITHDRAWN INTO THE SHEATH AND REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THE GUIDEWIRE WAS NOT STUCK IN THE VEIN. OUTSIDE THE PATIENT, THE GUIDEWIRE REMAINED IMMOBILE, AND IT WAS SUSPECTED THAT TISSUE WAS OBSTRUCTING THE GUIDEWIRE LUMEN. THE CATHETER AND GUIDEWIRE WERE BOTH REPLACED. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812952 PV-TRACKER GUIDE WIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC, INC. 990045 8831924 00643169530539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11