BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO ENT SYSTEM

    MDR report key: 7413155 · Received April 10, 2018

    Report

    Report Number
    2029046-2018-01419
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    PGW
    UDI-DI
    10846835017182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PROCEDURE WITH A CARTO ENT SYSTEM WHEREIN THE CARTO ENT NAVIGATION SYSTEM DID NOT ACCURATELY DISPLAY THE ANATOMY OF THE LEFT SIDED SINUSES. WHEN DILATION OF THE RIGHT-SIDED SINUSES WAS PERFORMED THE ANATOMY WAS DISPLAYED PROPERLY. WHEN THE LEFT-SIDED SINUSES WERE BEING DILATED THE SYSTEM STILL DISPLAYED THE BALLOON AS IF IN THE RIGHT-SIDED SINUSES. NO ERRORS WERE PRESENT ON THE EQUIPMENT AND NO PATIENT CONSEQUENCES WERE REPORTED DURING THE CASE. DEVICE EVALUATION SUMMARY: A BIOSENSE WEBSTER INC., FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE TO TROUBLESHOOT THE REPORTED ISSUE. IT WAS FOUND THAT THE METAL ON THE CHAIR WAS CAUSING SYSTEM TO FAIL CUBE TEST AND INACCURATE MAGNETIC LOCATION. WHEN PADDING WAS ADDED BETWEEN THE CHAIR AND CUBE, SYSTEM PASSED AND ISSUE RESOLVED. FSE ADVISED THE BWI REPRESENTATIVE AND THE CUSTOMER TO ADD A MATTRESS UNDER THE PATIENT. SYSTEM IS OPERATIONAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES, WHICH ARE RELATED TO THE REPORTED ISSUE WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PROCEDURE WITH A CARTO ENT SYSTEM WHEREIN THE CARTO ENT NAVIGATION SYSTEM DID NOT ACCURATELY DISPLAY THE ANATOMY OF THE LEFT SIDED SINUSES. WHEN DILATION OF THE RIGHT-SIDED SINUSES WAS PERFORMED THE ANATOMY WAS DISPLAYED PROPERLY. WHEN THE LEFT-SIDED SINUSES WERE BEING DILATED THE SYSTEM STILL DISPLAYED THE BALLOON AS IF IN THE RIGHT-SIDED SINUSES. THE CUSTOMER RE-REGISTERED ANATOMY TWICE WITH THE REGISTRATION PROBE WITHOUT RESOLUTION. NO ERRORS WERE PRESENT. THE PHYSICIAN ABANDONED USE OF THE NAVIGATION SYSTEM AND PROCEEDED WITH THE CASE MANUALLY WITH THE LUMA WIRE. ON 04/06/2018, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ULTIRRA BALLON WITHOUT NAVIGATION. IT ALSO CONFIRMS THAT NO PATIENT CONSEQUENCES WERE REPORTED DURING THE CASE. THE PATIENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION NEITHER EXTENDED HOSPITALIZATION, HOWEVER, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260188 CARTO ENT SYSTEM EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW BIOSENSE WEBSTER INC 10846835017182

    Patients

    Seq Age Sex Outcome Treatment
    1