BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 8525029 · Received April 17, 2019

    Report

    Report Number
    9612164-2019-01394
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 25, 2019
    Report Date
    June 19, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE MAPPING CATHETER 990063-020 WITH LOT 216868941 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE MAPPING CATHETER SHOWED THE LOOP WAS SEPARATED FROM THE PEBAX. THE LOOP HAS SEVERAL KINKS, ONE KNOT AND ELECTRODE WERE DISPLACED. IN CONCLUSION, THE REPORTED MAPPING CATHETER KINK WAS CONFIRMED THROUGH TESTING. THE MAPPING CATHETER 990063-020 WITH LOT FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE LOOP SEPARATION FROM THE PEBAX, SEVERAL KINKS, ONE KNOT, AND ELECTRODE DISPLACEMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS OBSERVED TO BE KINKED BY FLUOROSCOPY. THE MAPPING CATHETER WAS REPLACED WITH RESOLUTION. 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
    317637 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 216868941

    Patients

    Seq Age Sex Outcome Treatment
    1