BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 8213092 · Received January 3, 2019

    Report

    Report Number
    9612164-2019-00035
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    November 26, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE MAPPING CATHETER WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE REPORTED MAPPING CATHETER 990063-020, LOT NUMBER 216062145 SHOWED THE SHAFT WAS BROKEN AT 30 CENTIMETERS FROM THE LEMO CONNECTOR. IT WAS SUSPECTED THAT THE MAPPING CATHETER WAS KINKED BEFORE IT WAS BROKEN. IN CONCLUSION, THE REPORTED MAPPING CATHETER SHAFT KINK ISSUE WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE REPORTED MAPPING CATHETER 990063-020, LOT NUMBER 216062145 FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE SHAFT KINK 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 MAPPING CATHETER KINKED. THE PRODUCT WAS NOT REPLACED. 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
    4436 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 216062145

    Patients

    Seq Age Sex Outcome Treatment
    1