BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 4950541 · Received July 29, 2015

    Report

    Report Number
    1723170-2015-00937
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 30, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN REQUESTED. MEDTRONIC INVESTIGATION OF SUSPECT .6MM CORE FIBER 15MM TIP, RETURNED TO MANUFACTURER ON (B)(4) 2015, FINDS THAT THE END OF THE FIBER HAS BEEN BENT, BUT NOT ABLE TO SEE ANY CHARRING. ENGINEERING FINDINGS: MAGNIFIED VIEW OF THE TIP OF THE CATHETER HAS MELTED THROUGH, POSSIBLY LEAKING SALINE FLUID FROM THE TIP. THE LASER DIFFUSING FIBER (LDF) WAS LIKELY POSITIONED CLOSE TO THE TIP OF THE CCS. RETURN REQUESTED. MEDTRONIC INVESTIGATION OF SUSPECT 1.85MM CATHETER INTRODUCER RETURNED TO MANUFACTURER ON 07/06/2015, FINDS THAT TIPS ARE CHARRED AS REPORTED. ENGINEERING FINDINGS: CATHETERS APPEARED IN TACT, BUT HAD VISIBLE CHAR AT THE TIP OF EACH. SOME UNKNOWN COMPONENT, NOT ASSOCIATED WITH VISUALASE, WAS RECEIVED WITH THE FIRST CATHETER. THIS UNKNOWN COMPONENT WAS A PLASTIC TUBE OF SOME SORT WITH OBVIOUS BLOOD FLUIDS STILL IN THE TUBING. AS A RESULT OF THIS VERY BLOODY TUBE IN THE BIOHAZARD BAG, THE INSPECTION TOOK PLACE ONLY THROUGH THE PLASTIC BAGGING. MAGNIFIED VIEW OF THE TIP OF THE TWO CATHETERS, AS VIEWED THROUGH THE BIOHAZARD BAG. THE TIP OF THE CATHETERS HAD MELTED THROUGH, POSSIBLY LEAKING SALINE FLUID FROM THE TIP. THE LDF WAS LIKELY POSITIONED CLOSE TO THE TIP OF THE CCS. (B)(4) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED: TARGET 2: NO TEST DOSE, 90/97% ON LASER CONTROL, SO ABOUT 27W REAL DOSE DELIVERED FOR 2 MINUTES, IMAGES GOOD, CCS GOOD AND MOVED TO 3RD TRAJECTORY. TARGET 3: NO TEST DOSE; 90/97% ON LASER CONTROL, APPROXIMATELY 27W REAL DOSE DELIVERED FOR 2 MINUTES, IMAGES GOOD. REMOVED CCS AND FOUND IT TO BE CHARRED, LDF NORMAL. NOTE: WHEN PACKAGING THE LDF FOR RETURN, THE FIBER SNAPPED, THIS OCCURRED AFTER THE SURGERY WAS COMPLETED. NO BURN RISK, NO DETECTABLE ODOR.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THE SURGEON SUCCESSFULLY PERFORMED TWO ADDITIONAL TRAJECTORIES WITH THE SECOND COOLING CATHETER SYSTEM (CCS)/ LASER DIFFUSING FIBER (LDF) THAT WAS OPENED. WHEN ABLATIONS WERE COMPLETED, AND THEY REMOVED THE CCS FROM THE PATIENT, IT WAS NOTED THAT THE CATHETER WAS CHARRED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE THERMAL THERAPY SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494392 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR