BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ACHIEVE 990063-020 MAPPING CATHETER

    MDR report key: 25072725 · Received May 4, 2026

    Report

    Report Number
    MW5187622
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT CRYO-ABLATION PROCEDURE. WHEN RETRACTING THE ACHIEVE LOOP CATHETER AND CRYOCATH BALLOON INTO THE FLEXCATH STEERABLE SHEATH POST PROCEDURE, IT WAS REPORTED THAT THERE WAS A LITTLE RESISTANCE. UPON INSPECTION THE ACHIEVE MAPPING CATHETER TIP WAS STRETCHED AND ELECTRODES WERE MISSING. WE PULLED ~70ML BLOOD AND NEGATIVE ON THE FLEXCATH WHEN REMOVING. WE DID FIND 7 OF THE 8 ELECTRODES WITHIN THE CATHETER AND REMOVED BLOOD. THE TIP OF THE MAPPING CATHETER WAS STRETCHED AND WIRE BROKEN INTERNALLY. IT IS UNKNOWN IF THE ENTIRETY OF THE CATHETER WAS SUCCESSFULLY REMOVED OR IF AN ELECTRODE AND TIP WERE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431158 MEDTRONIC ACHIEVE 990063-020 MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MEDTRONIC, INC. 990063-020 230693091

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention