BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 21969237 · Received May 6, 2025

    Report

    Report Number
    2182208-2025-02208
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 6, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 2ACH20 MAPPING CATHETER WITH LOT NUMBER 9210274 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE LOOP SEGMENT AREA SHOWED THE LOOP WAS RIBBED NEAR ELECTRODES 1, 2, 3, 4, 5. THE USER MAY HAVE EXPERIENCED INSERTION DIFFICULTIES DUE TO THIS ISSUE WHEN INTRODUCING THE MAPPING CATHETER INTO THE BALLOON CATHETER. VISUAL INSPECTION OF THE SHAFT SEGMENT AREA SHOWED THE SHAFT WAS KINKED APPROXIMATELY 9 INCHES FROM THE LEMO CONNECTOR. COAGULATED BLOOD BUILT ON THE MAPPING CATHETER SHAFT WAS OBSERVED AFTER EXTRACTION OF IT FROM THE RECEIVED BALLOON CATHETER. THE INSERTION COMPATIBILITY INSPECTION WAS PERFORMED WITH A TEST CATHETER AND THE RETURNED MAPPING CATHETER. AS RECEIVED, THE MAPPING CATHETER WAS INSERTED AND RETRACTED INTO THE BALLOON TEST CATHETER, ENCOUNTERING MINOR RESISTANCE. IN CONCLUSION, THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE RIBBED MATERIAL OBSERVED ON THE PEBAX TUBING AND A KINK/TWIST OBSERVED ON THE CATHETER SHAFT. 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 A MAPPING CATHETER COULD NOT ADVANCE THROUGH THE BALLOON. THE MAPPING CATHETER COULD NOT BE REMOVED FROM THE BALLOON CATHETER. THE CASE 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
    1896596 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 9210274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown