BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 17624859 · Received August 25, 2023

    Report

    Report Number
    2182208-2023-02374
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 10, 2023
    Report Date
    October 17, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    UDI-DI
    00643169590984
    PMA / PMN Number
    K162892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. 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

    UPDATE: E: INITIAL REPORTER PRODUCT EVENT SUMMARY: THE 2ACH20 MAPPING CATHETER WITH LOT 8232178 AND A DATA FILE CONTAINING ONE IMAGE WERE RETURNED AND ANALYZED. THE RETURNED PHOTO SHOWED A MAPPING CATHETER SHAFT KINK, AND A LABEL OF THE LOT NUMBER 8232178 WAS OBSERVED. VISUAL INSPECTION WAS PERFORMED, AND THE SHAFT WAS BROKEN APPROXIMATELY 58 INCHES FROM THE LEMO CONNECTOR. NO ELECTROCARDIOGRAM (ECG) SIGNAL WIRES WERE BROKEN. FUNCTIONAL TESTING WAS PERFORMED USING A MULTIMETER. THE MAPPING CATHETER WAS CONNECTED TO THE TEST CABLE, AND THE CONTINUITY AND IMPEDANCE MEASUREMENT BETWEEN THE ELECTRODES AND THE OTHER SIDE OF THE CABLE SHOWED THE ELECTRODE'S CONTINUITY AND IMPEDANCE TO THE CABLE WERE NORMAL. IN CONCLUSION, THE REPORTED MAPPING CATHETER KINK WAS CONFIRMED THROUGH DATA ANALYSIS AND PRODUCT ANALYSIS. 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 PRIOR TO A CRYO ABLATION PROCEDURE, THE DISTAL END OF THE MAPPING CATHETER WAS DANGLING FREELY WHEN REMOVED FROM THE PACKAGING. UPON FURTHER INSPECTION, IT WAS REPORTED THAT THE MAPPING CATHETER WAS KINKED. THE MAPPING CATHETER WAS SUBSEQUENTLY REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086553 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 8232178 00643169590984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown