BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN EXTEND CONTROL CATHETER

    MDR report key: 5365624 · Received January 13, 2016

    Report

    Report Number
    3006026430-2016-00001
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 15, 2015
    Report Date
    January 13, 2016
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DRA
    PMA / PMN Number
    K122275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PRODUCT MALFUNCTIONS REPORTED. THE ARTISAN EXTEND CATHETER PERFORMED ACCORDING TO THE APPROVED INSTRUCTION FOR USE. ALL ARTISAN EXTEND CATHETERS ARE TESTED FOR PERFORMANCE PRIOR TO RELEASE. THE ARTISAN EXTEND CATHETER DOES NOT PROVIDE ENERGY FOR ABLATION. BASED ON THE INFORMATION PROVIDED BY ST JUDE MEDICAL, THE PHYSICIAN ALLEGES THE HANSEN SHEATH TO BE THE CAUSE OF THE EVENT. THE DEVICE WAS DISCARDED AT THE TIME OF THE PROCEDURE AND WAS NOT RETRIEVABLE FOR INVESTIGATION. THE PATIENT RECOVERED AND WAS REPORTED AS IMPROVING THE FOLLOWING DAY. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, FOLLOWING AN AF ABLATION PROCEDURE USING A ST JUDE NAV X CATHETER AND HANSEN ARTISAN CATHETER, THE PATIENT EXPERIENCED A TAMPONADE IN RECOVERY. A PERICARDIOCENTESIS WAS PERFORMED DRAINING APPROXIMATELY 500ML OF BLOOD WHICH STABILIZED THE PATIENT. THE PATIENT RECOVERED AND WAS REPORTED IMPROVING THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22013 ARTISAN EXTEND CONTROL CATHETER ARTISAN EXTEND DRA HANSEN MEDICAL 12411 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other ST JUDE ENSITE VELOCITY (B)(4)