BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PV-TRACKER GUIDE WIRE

    MDR report key: 23156218 · Received September 26, 2025

    Report

    Report Number
    2182208-2025-04832
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    UDI-DI
    00643169530539
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 990045 PV-TRACKER GUIDEWIRE WITH LOT NUMBER 8831920 WAS RETURNED AND ANALYZED. AS RECEIVED, THE PV TRACKER WAS INSERTED THROUGH THE CATHETER AND EXITED THE TIP FOR APPROXIMATELY 8.75 INCHES, A RESIDUE WAS OBSERVED AT CATHETER TIP AND GUIDEWIRE JUNCTION. THE PV TRACKER WAS REMOVED, AND RESIDUE WAS STUCK ON THE GUIDEWIRE AT APPROXIMATELY 8.75 INCHES FROM THE TIP. IN CONCLUSION, PRESENCE OF TRACES OF MATERIAL (LIKELY TISSUE) ON THE PV TRACKER GUIDEWIRE WAS CONFIRMED. THE PV-TRACKER GUIDEWIRE PASSED THE RETURNED 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; PRODUCT ID: 10FCC13, PRODUCT TYPE: SHEATH 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

    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 CARDIAC ABLATION PROCEDURE, NAVIGATION WITH THE GUIDEWIRE WAS CHALLENGING DUE TO A SMALL LEFT ATRIUM WITH A PATENT FORAMEN OVALE. THE SHEATH AND ARRAY REPEATEDLY FELL BACK INTO THE RIGHT ATRIUM DURING ATTEMPTS TO ACCESS THE LEFT PULMONARY VEINS. IN AN EFFORT TO COMPENSATE, THE GUIDEWIRE WAS ADVANCED WIDELY INTO THE LEFT ATRIUM AND INSERTED INTO THE LEFT SUPERIOR PULMONARY VEIN IN AN ATTEMPT TO CATCH THE ARRAY WITH THE SHEATH. DURING THIS MANEUVER, SOME TISSUE WAS INADVERTENTLY CAUGHT ON THE GUIDEWIRE, AND THE GUIDEWIRE BECAME STUCK. THERE WAS TISSUE ADHERENCE TO THE GUIDEWIRE, BLOCKING ACCESS INTO THE CATHETER LUMEN. FORCE WAS APPLIED TO WITHDRAW THE ARRAY , RESULTING IN COMPLETE LOSS OF TRANSSEPTAL POSITION. DUE TO ANATOMICAL LIMITATIONS AND PROCEDURAL DIFFICULTIES, AN ALTERNATIVE SHEATH AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279212 PV-TRACKER GUIDE WIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC, INC. 990045 8831920 00643169530539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown