BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 20989683 · Received December 20, 2024

    Report

    Report Number
    2182208-2024-05418
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 13, 2024
    Report Date
    February 14, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 2ACH20 MAPPING CATHETER WITH LOT NUMBER 9010026 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE LOOP SEGMENT AREA SHOWED THE LOOP WAS TORN AND DAMAGED AT 0.1 INCH FROM THE TIP. VISUAL INSPECTION OF THE INTRODUCER SHOWED THE INTRODUCER/LOOP STRAIGHTENER WAS REMOVED FROM THE RETURNED MAPPING CATHETER. THE FUNCTIONAL TEST WAS PERFORMED USING A MULTIMETER AND THE MAPPING CATHETER WAS CONNECTED TO THE TEST CABLE. THE CONTINUITY AND IMPEDANCE MEASUREMENT BETWEEN THE ELECTRODES AND THE OTHER SIDE OF THE CABLE SHOWED THE ELECTRODE'S CONTINUITY AND IMPEDANCE TO THE CABLE WAS NORMAL. IN CONCLUSION THE REPORTED ELECTRODE DAMAGE WAS NOT CONFIRMED DURING TESTING AND THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A TEAR OBSERVED AT THE TIP/LOOP OF THE PEBAX TUBING AND THE INTRODUCER BEING REMOVED FROM THE MAPPING 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

    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, THE MAPPING CATHETER WAS STUCK AT THE Y VALVE OF THE BALLOON CATHETER. THE MAPPING CATHETER WAS PUSHED AND PULLED MULTIPLE TIMES WITHOUT RESOLUTION. AFTER THE MAPPING CATHETER WAS PULLED OUT OF THE BALLOON CATHETER FOR THE LAST TIME IT WAS OBSERVED THAT, "THE ELECTRODE AT THE TIP OF THE MAPPING CATHETER WAS DAMAGED." THE MAPPING CATHETER WAS REPLACED BY A MEDTRONIC PRODUCT. THE PROCEDURE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048995 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 9010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male