BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CATHETER SYSTEM

    MDR report key: 7872755 · Received September 13, 2018

    Report

    Report Number
    3004962788-2018-00049
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 27, 2018
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521545557
    PMA / PMN Number
    K102604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED HOWEVER PHOTOS WERE RECEIVED. THE PHOTOS SHOW A STRING LIKE SUBSTANCE COMING OUT OF THE EWC CATHETER. IT IS NOT CLEAR WHAT THE STRING LIKE SUBSTANCE IS FROM THE PHOTO. AT THIS TIME WITHOUT MORE INFORMATION AND THE EWC WITH THE STRING LIKE SUBSTANCE, NO CONCLUSION CAN BE MADE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED AND EVALUATED. THE COMPLAINT WAS VERIFIED AS PEELING OF THE LINER WAS FOUND ON THE EWC. THE MOST LIKELY CAUSE OF THE PEELING OF THE EWC LINER IS USE OF A TOOL WITH SHARP EDGES AS SCRATCHING/PEELING WAS FOUND ON THE OUTSIDE RADIUS OF THE CATHETER. HOWEVER, NO TOOLS WERE RETURNED SO THE ROOT CAUSE CANNOT BE DETERMINED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED BUT HAS NOT YET BEEN RETURNED. HOWEVER, THE REPORTED BEHAVIOR IS CONSISTENT WITH A KNOWN ISSUE IN WHICH AN INTERNAL CORRECTIVE ACTION WAS INITIATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE OF BOTH ENDOBRONCHIAL PROCEDURE KITS APPEARED TO MALFUNCTION. A THIN LINE OF PLASTIC BECOME SEPARATED OR SLICED FROM THE 180 CATHETER DURING OR AFTER THE PROCEDURE BY USE OF ADDITIONAL TOOLS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716090 EDGE CATHETER SYSTEM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC SDK4000-FT 505651 10884521545557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SUPERDIMENSION INREACH SYSTEM