BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 3810275 · Received May 14, 2014

    Report

    Report Number
    3007798852-2014-00008
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MDT ABLATION FRONTIERS MFG
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE RISK OF CARDIAC PERFORATION, PERICARDIAL EFFUSION AND TAMPONADE ASSOCIATED WITH CRYOABLATION FOR ATRIAL FIBRILLATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PATIENT HAD A PERICARDIAL EFFUSION DURING AN ABLATION PROCEDURE. THE PHYSICIAN WAS MANIPULATING THE MAPPING CATHETER INTO THE LEFT SUPERIOR PULMONARY VEIN AND NOTICED A PERICARDIAL EFFUSION ON ULTRASOUND. ECHO WAS CALLED AND THE DIAGNOSIS WAS CONFIRMED. THE EVENT OCCURRED PRIOR TO ANY ABLATION BEING PERFORMED. THE PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED WITH OVER 700CC OF BLOOD EVACUATED. THE PATIENT'S BLOOD PRESSURE WAS NORMAL AFTER THE PERICARDIOCENTESIS. AS PER THE PHYSICIAN, THE EFFUSION IS BELIEVED TO HAVE OCCURRED EITHER DURING THE EXCHANGE OF THE TRANSSEPTAL SHEATH FOR THE STEERABLE SHEATH OR DURING THE MAPPING OF THE LEFT ATRIUM. THERE WERE NO ISSUES WITH THE DEVICES DURING THE PROCEDURE. DEVICE 2 OF 2, REFERENCE MFR REPORT: 3002648230-2014-00082.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288456 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MDT ABLATION FRONTIERS MFG 990063-015 0007009923

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention FLEXCATH ADVANCE STEERABLE SHEATH MODEL 4FC12