BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 12778036 · Received November 9, 2021

    Report

    Report Number
    1723170-2021-02652
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    November 5, 2021
    Report Date
    June 20, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GAH
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    SEE B5. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN PLACING THE CATHETER USING A NON-MEDTRONIC SYSTEM, THE SURGEON WAS USING THE VISUALIZATION STYLET AND WHEN THEY PLACED THE CATHETER, THE STYLET AND CATHETER CREATED A SUCTION AND IT WAS NOT POSSIBLE TO REMOVE THE STYLET. THE SURGEON HAD TO PULL OUT THE CATHETER/STYLET AND OPEN NEW ONES AND WAS ABLE TO GET THE CATHETER PLACED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A NEURO ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676818 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC 9735566 2020100410

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male