BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 1048319 · Received May 20, 2008

    Report

    Report Number
    3006026430-2008-00009
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K052480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INVESTIGATION INTO THE FAILURE IDENTIFIED A SMALL NUMBER OF CATHETERS WITH THE POTENTIAL FOR DEVELOPING A SIMILAR LEAK. THE COMPANY IS INITIATING A RECALL OF ALL AFFECTED PRODUCT OUT OF AN ABUNDANCE OF CAUTION. ARTISAN WAS EVALUATED ACCORDING TO STANDARD FAILURE ANALYSIS PROTOCOL. THE REPORTED LEAK WAS CONFIRMED WITH THER FOLLOWING NOTES: GROSS DELAMINATION OF BELLOWS JOINT, APPROX 270 DEGREES OF BOND CENTERED ABOUT TOP DEAD CENTER. EVIDENCE OF CURED ADHESIVE ON BOTH BELLOWS AND BELLOWS SLEEVE. FOLLOW-ON INVESTIGATION INTO THE FAILURE IDENTIFIED THAT THE LOCATION OF THE HOLE IN THE BELLOWS AND AMOUNT OF JOINT FILLET WAS AN IMPORTANT CONTROL PARAMETER TO ENSURE RELIABILITY OFTHE CATHETER. PREVIOUS PROCESS IMPROVEMENTS AT THE VENDOR HAD ELIMINATED VARIATION OF THESE PARAMETERS. THE INVESTIGATION IDENTIFIED ALL POTENTIAL SERIAL NUMBERS WHICH HAD A POTENTIAL SERIAL NUMBERS WHICH HAD A POTENTIAL FOR DEVELOPING A LEAK AND THE RESULTING HEALTH HAZARD PRESENTED BY THE ISSUE AS "LOW".

    Description of Event or Problem · 1

    AN ABLATION CATHETER WAS INSERTED INTO THE ARTISAN CATHETER AND THE ARTISAN CATHETER WAS THEN INTRODUCED INTO THE PT'S BODY. DURING INSERTION OF THE ARTISAN CATHETER, THE PROXIMAL AND WAS STRESSED AS A RESULT OF THE ABLATION CATHETER BEING UNSUPPORTED. AFTER INTRODUCTION INTO THE RIGHT ATRIA, AIR WAS OBSERVED IN THE HEMOSTASIS VALVE. UPON INVESTIGATION, A LEAK WAS OBSERVED AT THE FLEXIBLE BELLOWS PORTION OF THE PROXIMAL PORTION OF THE ARTISAN CATHETER AND THE CATHETER WAS REMOVED FROM THE PT. THERE WAS NO PT INJURY. A REPLACEMENT CATHETER WAS UTILIZED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHERTER, STEERABLE DRA HANSEN MEDICAL, INC. 04454 022108

    Patients

    Seq Age Sex Outcome Treatment
    1