BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 3863848 · Received June 10, 2014

    Report

    Report Number
    3002648230-2014-00095
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A PERICARDIAL EFFUSION OCCURRED FOLLOWING MULTIPLE ATRIAL TRANSSEPTAL ATTEMPTS. DOUBLE TRANSSEPTAL PUNCTURES WERE PERFORMED, THE SHEATH WAS INTRODUCED AND THE CRYOABLATION CATHETER WAS INTRODUCED OVER A ROSEN WIRE. BEFORE CRYOBALLOON INFLATION PERICARDIAL FLUID WAS DIAGNOSED BY FLUOROSCOPY AND INTRA CARDIAC ECHO. ALL INSTRUMENTS WERE REMOVED FROM THE LEFT ATRIUM, PROTAMINE WAS ADMINISTERED AND A PERICARDIOCENTESIS PERFORMED. 480 ML OF RED FLUID WAS WITHDRAWN FROM THE PERICARDIAL SPACE. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE CRYOABLATION PROCEDURE WAS ABORTED. THERE WERE NO ALLEGED PRODUCT ISSUES REPORTED DURING THE CASE. DEVICE 2 OF 2, REFERENCE MFR REPORT: 3002648230-2014-00094.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339233 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 00440

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention ARCTIC FRONT ADVANCE CATHETER, MODEL 2AF284