BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 7267972 · Received February 13, 2018

    Report

    Report Number
    9612164-2018-00349
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    August 28, 2017
    Report Date
    February 13, 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 AT LEAST FOUR APPLICATIONS WERE PERFORMED WITH CATHETER 2AF283/62335-43 AND TWO APPLICATIONS WITH CATHETER 2AF283/79027-22 ON THE DATE OF EVENT. THE TEMPERATURE AND PRESSURE DID NOT REACH TO MINIMUM ACCEPTABLE RANGE IN ALL APPLICATIONS AND FLOW HAD HIGH FLUCTUATION AND LOW PROFILE IN THE INJECTION. THE DATA FILES SHOWED AT LEAST SEVENTEEN APPLICATIONS WERE PERFORMED WITH CATHETER 2AF283/46523-07 ON THE DATE OF THE EVENT AND MULTIPLE APPLICATIONS HAD FLOW, TEMPERATURE AND PRESSURE PROBLEMS. UPON VISUAL INSPECTION OF THE ACHIEVE MAPPING CATHETER 990063-020/ 213632001, RESULTS SHOWED THE TIP OF THE LOOP WAS DAMAGED AND THE SHAFT WAS KINKED NEAR THE LEMO CONNECTOR. THE CATHETER WAS CONNECTED TO THE DIAGNOSTIC COMPUTER AND CHANNEL PAIRS 7-8 AND 8-1 WERE DISPLAYING NOISES. DISSECTION OF THE CATHETER RESULTS SHOWED THE ELECTRODES-WIRE OF PIN # 8 HAD BEEN BROKEN INSIDE THE LEMO CONNECTOR. DISSECTION OF THE RING DID NOT SHOW ANY WELDING ISSUE. BLOOD WAS ALSO DISCOVERED INSIDE THE PEBAX SHAFT THAT SUGGESTED THE FAILURE OCCURRED DURING USE. IN CONCLUSION, MAPPING CATHETER NOISE HAS BEEN CONFIRMED THROUGH TESTING. THE MAPPING CATHETER 990063-020 / 213632001 FAILED THE RETURNED PRODUCT INSPECTION DUE TO BROKEN ELECTRODE-WIRES. 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, FLOW WAS ERRATIC AND PRESSURE VALUES WERE NOT AS EXPECTED. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. ADDITIONALLY, FROST WAS OBSERVED AT THE BALLOON CATHETER CONNECTION. THE CATHETER WAS REPLACED TWICE WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE THEN BOTH REPLACED. IT WAS ALSO REPORTED THAT THE MAPPING CATHETER EMITTED NOISE AND DEVELOPED A BREAK IN THE WIRES. THE MAPPING CATHETER WAS REPLACED, AND 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
    110872 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC MEXICO 990063-020 213632001

    Patients

    Seq Age Sex Outcome Treatment
    1