BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 21942126 · Received May 1, 2025

    Report

    Report Number
    2182208-2025-02154
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    Adverse Event
    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 9210266 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE LOOP SEGMENT AREA SHOWED THE LOOP WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE WAS OBSERVED ALONG WITH THE TIP/LOOP SECTION OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE PEBAX TUBING AREA SHOWED THE PEBAX TUBING WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE WAS OBSERVED ALONG WITH THE PEBAX TUBING SECTION OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE ELECTRODE(S) SHOWED THE ELECTRODE(S) WAS INTACT WITH NO APPARENT ISSUES. ALL ELECTRODES EXISTED ON THE LOOP SECTION AND NO COSMETIC ISSUE OR ANOMALIES WERE IDENTIFIED. VISUAL INSPECTION OF SHAFT SEGMENT AREA SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. NO KINK OR ANY OTHER DAMAGE WAS OBSERVED ALONG WITH THE SHAFT OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE INTRODUCER SHOWED THE INTRODUCER WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE INTRODUCER. VISUAL INSPECTION OF THE LEMO CONNECTOR SHOWED THE LEMO CONNECTOR WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE LEMO CONNECTOR. THE FUNCTIONAL TEST WAS PERFORMED USING A MULTIMETER. 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 ARE NORMAL. IN CONCLUSION, THE CLINICAL ISSUE (TAMPONADE AND PERICARDIAL EFFUSION) OCCURRED DURING THE PROCEDURE WITH NO INDICATION THAT THE ADVERSE EVENT WAS RELATED TO THE PERFORMANCE OR A MALFUNCTION OF THE PRODUCT. THE REPORTED CLINICAL ISSUES CAN NOT BE ASSESSED THROUGH DATA ANALYSIS. THE MAPPING CATHETER 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

    PRODUCT ID: 4FC12 PRODUCT TYPE: SHEATH PRODUCT ID: AFAPRO28 PRODUCT TYPE: BALLOON 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 CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL TAMPONADE DURING THE OPERATION. THE ABLATION WAS HALTED AND PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE TAMPONADE AND EFFUSION. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207698 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 9210266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L SEE H11