BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIST CATHETER

    MDR report key: 12910046 · Received December 1, 2021

    Report

    Report Number
    2029214-2021-01545
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    June 30, 2021
    Report Date
    December 28, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, THIS EVENT HAD BEEN PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 2029214-2021-01374. ANY FURTHER UPDATES WILL BE SUBMITTED IN THAT REPORT. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO DEVICE DEFICIENCY WITH THE CATHETER. THE INCORRECT SIZE WAS USED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE RIST CATHETER WAS TOO LONG. IN ADDITION, AFTER THE PROCEDURE WAS COMPLETE THE PATIENT EXPERIENCED A STROKE. IT WAS REPORTED THAT THE RIST CATHETER WAS TOO LONG. IN ADDITION, AFTER THE PROCEDURE WAS COMPLETE THE PATIENT EXPERIENCED A STROKE/CEREBRAL INFARCTION WITH TRANSIENT SIGNS, WHICH WAS RESOLVED ON (B)(6) 2021 WITH NO TREATMENT REQUIRED. THE SECOND RIST CATHETER PROVIDED GOOD NAVIGABILITY AND SUPPORT. THE ASSESSMENT SITE AND SPONSOR DETERMINED THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE RIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807787 RIST CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RIST 16741-01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other