BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSYS CATHETER

    MDR report key: 14540002 · Received May 30, 2022

    Report

    Report Number
    3014251914-2022-00008
    Event Type
    Injury
    Date Received
    May 30, 2022
    Date of Event
    May 11, 2022
    Report Date
    September 8, 2022
    Manufacturer
    AVENU MEDICAL
    Product Code
    PQK
    PMA / PMN Number
    K191114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PATIENT RETURNED FOR FOLLOW UP ULTRASOUND, STATED ARM FELT FINE AND NO COMPLAINTS AFTER THE PROCEDURE. FISTULA AND ALL OTHER VASCULATURE INVOLVED PATENT. 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.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE AN ELLIPSIS CATHETER TO TREAT A PATIENT. IT WAS REPORTED THAT THE PHYSICIAN INSISTED ON DOING RE-CREATION WITH 2ND CATHETER 2 DAYS POST 1ST CREATION, DUE TO THROMBOSED ANASTOMOSIS. THE PROCEDURE WAS COMPLETED BY A SHARP RECANALIZATION OF THROMBOSED ANASTOMOSIS, WIRE, INTRODUCER WITH DILATOR, CATHETER AND BALLOON ANGIOPLASTY OF THE ANASTOMOSIS, THE SAME WAY THE ORIGINAL CREATION WAS DONE. MONITORING TO SEE THE NEW ANASTOMOSIS AND OLD ANASTOMOSIS DEVELOP AS WELL AS CHECK ON THE DISTAL RADIAL ARTERY. THE PATIENT¿S LEFT ARM MATURATION CASE, 2 DAYS POST CREATION WITH INABILITY TO BALLOON ANASTOMOSIS AT TIME OF CREATION DUE TO LOSING THE WIRE. STARTED WITH KNOWN SOFT THROMBOSE SEEN ON ULTRASOUND IN THE ANASTOMOSIS. PHYSICIAN STARTED WITH DISTAL RADIAL ARTERY ACCESS. HEMATOMA CAUSED FROM INFILTRATION DURING ACCESS AT DISTAL RADIAL ARTERY WAS OBSERVED VISUALLY. PHYSICIAN DIDN¿T ACKNOWLEDGE OR SEEM TO BE CONCERNED. HEMATOMA HAD DISSIPATED SIGNIFICANTLY BY END OF PROCEDURE. AFTER SEVERAL ATTEMPTS PHYSICIAN WAS NOT ABLE TO GET ACROSS ANASTOMOSIS FROM DISTAL RADIAL ARTERY ACCESS. WENT TO RETROGRADE CEPHALIC TO TRY SHARP RECANALIZATION FOR PTA. PHYSICIAN AT THIS POINT WAS CONCERNED ABOUT UNCERTAINTY OF BEING IN THE EXACT SAME ANASTOMOSIS AND ASKED ABOUT DOING A SECOND CREATION WITH THE ELLIPSYS CATHETER. AFTER CONFIRMING WITH HIM THAT WAS WHAT HE WANTED TO DO WE PROCEEDED AND CREATED A NEW ANASTOMOSIS. SUCCESSFUL 2ND CREATION COMPLETED THROUGH CLOT WITH PTA IMMEDIATELY FOLLOW WITH DISTAL BRACHIAL ARTERY FINAL FLOW VOLUME OF 199 ML/MIN. WE HAVE RECOMMENDED PATIENT RETURN FOR 1 WEEK FOLLOW UP ULTRASOUND. NO FURTHER PATIENT STATUS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713361 ELLIPSYS CATHETER PERCUTANEOUS CATHETER FOR CREATION OF AN ARTER PQK AVENU MEDICAL AMI6005 000572

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention