BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PV-TRACKER GUIDE WIRE

    MDR report key: 23657379 · Received November 26, 2025

    Report

    Report Number
    2182208-2025-10575
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    UDI-DI
    00643169530539
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 990045 GUIDEWIRE OF LOT NUMBER 8831920 WAS RETURNED AND ANALYZED. THE RETURNED GUIDEWIRE WAS INSERTED INTO THE RETURNED CATHETER AND RETRACTED WITHOUT ANY ISSUES. IN CONCLUSION, REPORTED ¿TISSUE¿ COULD NOT BE REPRODUCED. THE GUIDEWIRE PASSED THE RETURN PRODUCT INSPECTION. 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE PV TRACKER GUIDEWIRE COULD NOT BE PULLED INTO THE CATHETER AND RESISTANCE WAS FELT. THE CATHETER AND GUIDEWIRE WERE RETRACTED OUT OF THE PATIENT, AND IT WAS FOUND THAT THE CATHETER HAD INVERTED, POSSIBLY FROM OVER ROTATION WHILE IN CONTACT WITH THE PULMONARY VEIN. TISSUE WAS PRESENT IN THE NOSE OF THE CATHETER, OBSTRUCTING MOVEMENT OF THE WIRE. THE WIRE WAS FORCEFULLY ADVANCED, DISLODGING THE TISSUE. THE WIRE WAS THEN REMOVED, THE LUMEN OF THE CATHETER WAS FLUSHED, THE INVERSION WAS CORRECTED BY MANUAL MANIPULATION, AND A NEW WIRE WAS INSERTED INTO THE LUMEN. 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
    2030258 PV-TRACKER GUIDE WIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC, INC. 990045 8831920 00643169530539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11