BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUMA Z2 7F GUIDE CATHETER

    MDR report key: 10147573 · Received June 12, 2020

    Report

    Report Number
    1220452-2020-00048
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 6, 2020
    Report Date
    August 25, 2020
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    UDI-DI
    00613994810519
    PMA / PMN Number
    K000677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: ONE 7F ZUMA2 GUIDE CATHETER WAS RECEIVED FOR ANALYSIS. A KINK WAS NOTED MID SHAFT APPROX. 65CM DISTAL TO THE STRAIN RELIEF. A DETACHMENT OF THE PRIMARY SEGMENT FROM THE SHAFT WAS NOTED ON THE RETURNED DEVICE. THE DEVICE APPEARED TO BE HELD TOGETHER ONLY BY BRAID WIRE. THE OD OF THE DEVICE MEASURED 0.094¿ MEETING SPECIFICATION OF 0.0949¿ MAX. THE ID MEASURED 0.081¿ MEETING SPECIFICATION OF 0.0805¿ MINIMUM. NO OTHER DEFORMATION NOTED. CORRECTION: THE CORRECT PMA NUMBER IS K000677. 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

    ADDITIONAL INFORMATION: THE GUIDE CATHETER WAS INSPECTED BEFORE USE. THE 7F ZUMA2 WAS PREPPED AS PER IFU. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE AS IT WAS A DIFFICULT TORTUOUS CASE.EXCESSIVE FORCE WAS USED. IT WAS LATER REPORTED THAT THE CATHETER DID NOT FULLY DETACH. THE CATHETER WAS WITHDREW AFTER EXCESSIVE TORQUING. IT WAS STATED THAT THE CATHETER BROKE IN TWO HOWEVER THE BRAID KEPT IT IN PLACE. IT WAS STATED THAT THIS WAS NOT A PRODUCT FAILURE AND BELIEVES THAT IT WAS DUE TO THE ECTATIC RCA THAT WAS VERY TORTUOUS. 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 · 1

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

    Description of Event or Problem · 1

    A 7F ZUMA2 GUIDE CATHETER WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE GUIDE CATHETER BROKE MID CASE WHEN THE DEVICE WAS INSIDE THE PATIENT. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614880 ZUMA Z2 7F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC Z27EBU35 0010081839 00613994810519

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR