BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE TITANIUM TROCAR 1.85MM

    MDR report key: 5657676 · Received May 16, 2016

    Report

    Report Number
    1723170-2016-00235
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    June 22, 2015
    Report Date
    November 5, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K053087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE WAS UNAVAILABLE. HARDWARE INVESTIGATION WAS COMPLETED. DURING MR TESTING, HEATING OF THE TROCAR AND VISUALIZATION STYLET WAS OBSERVED, REQUIRING SPECIFIC LABELING TO CONVEY SAFE USE TO PREVENT THIS HEATING. THIS ISSUE WAS FOUND RELATED TO A HARDWARE LABELLING ISSUE AND WAS DOCUMENTED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE. A CAPA INVESTIGATION WAS OPENED TO ADDRESS THIS CONCERN.

    Additional Manufacturer Narrative · 1

    AS PREVIOUSLY REPORTED, A CAPA INVESTIGATION WAS OPENED TO ADDRESS THIS CONCERN; THE INVESTIGATION IDENTIFIED A PRIMARY AND SECONDARY ROOT CAUSE. THE PRIMARY ROOT CAUSE WAS AT THE TIME MEDTRONIC BECAME THE MANUFACTURER OF RECORD, MEDTRONIC RELIED ON THE RATIONALE PROVIDED BY (B)(4) IN THEIR 510K SUBMITTAL, AND THE RATIONALE DID NOT ACCURATELY ACCOUNT FOR THE PROPERTIES OF THE MATERIAL USED. THE SECONDARY ROOT CAUSE WAS FOUND TO BE THAT (B)(4) DID NOT CONDUCT TESTING OF THE PRODUCT ITSELF TO VALIDATE THE RATIONALE PROVIDED FOR THE ORIGINAL LABELING. MEDTRONIC HAS PERFORMED ADDITIONAL MR SAFETY TESTING ON THE REPORTED INSTRUMENTATION. OF THE AFFECTED PRODUCTS INTENDED FOR USE IN THE MR ENVIRONMENT ALL HAVE BEEN TESTED BY MEDTRONIC WITH RESPECT TO FORCE/TORQUE AND ALL ARE ACCEPTABLE. IN ADDITION, COMPONENTS THAT ARE EXPECTED TO BE IMAGED IN AN MRI WERE TESTED FOR HEATING AND ARTIFACT. THIS INCLUDES THE TROCAR AND VISUALIZATION STYLET. BASED ON THE TESTING, THERE IS THE POSSIBILITY OF HEATING OF THE TROCAR AND STYLET, WHICH WOULD RESULT IN AN INCREASE IN TEMPERATURE. THE HEATING WOULD OCCUR AT A LOCALIZED POSITION IN THE PATIENT WHERE THE TISSUE WAS ALREADY DAMAGED BY INSERTION OF THE TROCAR/STYLET. IN ORDER FOR THE TEMPERATURE INCREASE TO OCCUR, THE INSTRUMENT NEEDS TO BE IN A SPECIFIC ORIENTATION WITH RESPECT TO THE MR ENERGY FIELD (I.E., SOME ORIENTATIONS ABSORB THE RF ENERGY BETTER THAN OTHERS). IT IS RF ENERGY IN THE SCAN THAT HEATS UP THE PRODUCT, AND SOME SCAN SEQUENCES GENERATE MORE RF ENERGY THAN OTHERS. THE AMOUNT OF RF ENERGY GENERATED BY A PARTICULAR SCAN SEQUENCE IS CAPTURED IN THE SPECIFIC ABSORPTION RATE (SAR) VALUE FOR A SCAN. HIGHER SAR VALUES IMPLY AN INCREASED RF ENERGY, AND WILL RESULT IN MORE HEATING OF A DEVICE. AS PART OF THE CAPA INVESTIGATION A SAFETY RISK MANAGEMENT REVIEW WAS COMPLETED AND FOUND THE OVERALL RESIDUAL RISK ASSOCIATED WITH THIS ISSUE HAS NOT CHANGED. A REVIEW OF THE COMPLAINT HISTORY RELATED TO THIS ISSUE FOUND NO COMPLAINTS ORIGINATING FROM A CLINICAL SETTING. THE ONLY COMPLAINTS RELATED TO THIS ISSUE WERE IDENTIFIED DURING INTERNAL TESTING. THERE HAVE BEEN NO REPORTS OF THIS FAILURE MODE AFFECTING A PATIENT OR THE USER OF THE DEVICE. THE COMPLIANCE RISK FOR THE MR COMPATIBILITY LABELING IS CONSIDERED LOW. THIS IS BASED ON THE FACT THAT THE VISUALASE ACCESSORIES KITS, OF WHICH THE TROCAR AND VISUALIZATION STYLET INSTRUMENTS ARE INCLUDED IN, ARE FDA CLASS I DEVICES THAT DO NOT REQUIRE A 510(K) OR OTHER PRIOR APPROVAL BY FDA. THE TROCAR AND VISUALIZATION STYLET INSTRUMENTS THAT WERE LABELED AS MR COMPATIBLE, WERE COMPLIANT TO THE REQUIREMENTS AT THE TIME THAT THEY WERE RELEASED. THE MR COMPATIBILITY LABELING FOR THE VISUALASE COOLED LASER ABLATION SYSTEM (VCLAS) WAS CLEARED IN K053087, WHICH WAS COMPLIANT TO MR LABELING REQUIREMENTS IN PLACE AT THE TIME OF CLEARANCE. THE REPORTED DOCUMENTATION REGARDING THE MR COMPATIBILITY FOR THE VCLAS SUPPORTS THE LABELING AND WAS PROVIDED BY (B)(4). DOCUMENTATION REGARDING MR COMPATIBILITY OF THE CLASS I ACCESSORIES WAS NOT PROVIDED BY (B)(4), ALTHOUGH BASED ON THE MATERIAL COMPOSITION AND USE OF THE ACCESSORIES, A MR COMPATIBILITY CLASSIFICATION IS SUPPORTED. TESTING PERFORMED BY MEDTRONIC SUPPORTS THE LABELING OF THESE DEVICES AS MR CONDITIONAL PER THE CURRENT MR LABELING REQUIREMENTS WITH LABEL UPDATES PROVIDING ADDITIONAL INFORMATION DESCRIBING THE CONDITIONS FOR SAFE USE. NEW PRODUCT WILL BE LABELED PER CURRENT FDA GUIDANCE AND STANDARDS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER AND DEVICE MANUFACTURING DATE FOR THE CONCOMITANT VISUALIZATION STYLET WAS IDENTIFIED AS 142230 AND 05/06/2014, RESPECTIVELY. DEVICE MANUFACTURING DATE FOR THE TROCAR STYLET NOW PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A LABELING ISSUE, REGARDING MR COMPATIBILITY VS. CONDITIONAL, IDENTIFIED DURING IN-HOUSE TESTING OF THE TROCAR & VISUALIZATION STYLET. BIOTEX MEDICAL ORIGINALLY LABELED THE DEVICES AS BEING MR COMPATIBLE (INCLUDING TROCAR & VISUALIZATION STYLET). HOWEVER, RECENT TESTING BY MEDTRONIC DEMONSTRATED THAT THESE DEVICES SHOULD BE LABELED AS MR CONDITIONAL, AND THE CONDITIONS FOR SAFE USE INCLUDED IN THE LABELING. EACH DEVICE HAS ITS OWN LABELING. THIS ISSUE WAS IDENTIFIED OUTSIDE OF CLINICAL SETTING. THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312371 VISUALASE TITANIUM TROCAR 1.85MM POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 142503

    Patients

    Seq Age Sex Outcome Treatment
    1