BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 7237496 · Received February 2, 2018

    Report

    Report Number
    9612164-2018-00194
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    September 29, 2017
    Report Date
    February 2, 2018
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES SHOWED FOUR INJECTIONS WERE PERFORMED WITH CATHETER 2AF283/12131-21 WITHOUT ANY ISSUES OR SYSTEM NOTICES. UPON VISUAL INSPECTION OF ACHIEVE MAPPING CATHETER 990063-020 / 213478292, RESULTS SHOWED THE LOOP ARRAY WAS DAMAGED AND A KNOT WAS OBSERVED 0.62IN FROM THE TIP. FURTHERMORE, THE CATHETER SHAFT WAS BROKEN 11 INCHES FROM THE TIP. ADDITIONAL INSPECTION UNDER MICROSCOPE DID NOT REVEALED ANY KINK ON PEBAX SHAFT. THE REPORTED ISSUE DOES NOT INDICATE A MAPPING CATHETER¿S MANUFACTURING RELATED DEFECT. IN CONCLUSION, THE REPORTED ISSUE (ACHIEVE TIP DAMAGE/BROKEN) WAS CONFIRMED THROUGH TESTING. THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A DAMAGED TIP/LOOP SECTION AND BROKEN SHAFT. 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 TIP OF THE MAPPING CATHETER BROKE WHEN IT WAS PULLED BACK INTO THE SHEATH FOR ADDITIONAL ABLATION. THE BROKEN END OF CATHETER WERE SUCCESSFULLY REMOVED WITH THE SHEATH, AS CONFIRMED VIA XRAY. THE CASE WAS COMPLETED WITH CRYO. THE MAPPING CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82030 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 213478292

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR