BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 17512369 · Received August 11, 2023

    Report

    Report Number
    2182208-2023-02219
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 19, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    UDI-DI
    00643169590984
    PMA / PMN Number
    K162892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 2ACH20 MAPPING CATHETER WITH LOT NUMBER 8232176 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE LOOP SEGMENT AREA SHOWED THE LOOP WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE WAS OBSERVED ALONG WITH THE TIP/LOOP SECTION OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE PEBAX TUBING AREA SHOWED THE PEBAX TUBING WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE WAS OBSERVED ALONG WITH THE PEBAX TUBING SECTION OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE ELECTRODES SHOWED THE ELECTRODES WERE INTACT WITH NO APPARENT ISSUES. ALL ELECTRODES EXIST ON THE LOOP SECTION AND NO COSMETIC ISSUE OR ANOMALIES WERE IDENTIFIED. THE SHAFT SEGMENT AREA SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. NO KINK OR ANY OTHER DAMAGE WAS OBSERVED ALONG WITH THE SHAFT OF THE MAPPING CATHETER. THE INTRODUCER SHOWED THE INTRODUCER WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE INTRODUCER. THE LEMO CONNECTOR SHOWED THE LEMO CONNECTOR WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE LEMO CONNECTOR. THE FUNCTIONAL TEST WAS PERFORMED USING A MULTIMETER 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 ARE NORMAL. THE INSERTION COMPATIBILITY INSPECTION WAS PERFORMED WITH THE TEST CATHETER AND THE RETURNED MAPPING CATHETER. NO ANOMALIES WERE IDENTIFIED. AS RECEIVED, THE MAPPING CATHETER WAS INSERTED AND RETRACTED INTO THE BALLOON TEST CATHETER WITHOUT ANY ISSUE. THE MAPPING CATHETER WAS INTACT WITH NO APPARENT ISSUES. NO KINKS WERE OBSERVED ALONG WITH THE SHAFT, PEBAX, OR TIP/LOOP SECTION OF THE MAPPING CATHETER. IN CONCLUSION, THE CLINICAL ISSUE OF A CLOT OCCURRED DURING THE PROCEDURE WITH NO INDICATION THAT THE ADVERSE EVENT WAS RELATED TO THE PERFORMANCE OR A MALFUNCTION OF THE PRODUCT AND THE MAPPING CATHETER PASSED THE RETURNED PRODUCT INSPECTION. 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

    CONTINUATION OF D10: PRODUCT ID: AFAPRO28, PRODUCT TYPE: ARCTIC FRONT CATHETER; PRODUCT ID: 4FC12, PRODUCT TYPE: FLEXCATH SHEATH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A "POTENTIAL" CLOT WAS OBSERVED IN THE LEFT ATRIUM VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT WAS NOT PRESENT PRIOR TO TRANSEPTAL ACCESS AND THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE CLOT. THE FIRST ABLATION WAS PERFORMED, AND THEN THE BALLOON CATHETER,  MAPPING CATHETER, AND SHEATH WERE REMOVED. THE BALLOON CATHETER AND SHEATH WERE FLUSHED AND ASPIRATED. THERE WAS NO SIGN OF A CLOT ON ANY OF THE PRODUCTS. THE ACTIVATED CLOTTING TIME WAS GREATER THAN FOUR HUNDRED SECONDS. ICE WAS UTILIZED AGAIN AND NO CLOT WAS OBSERVED. DESPITE THE CONCERNS, THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564443 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 8232176 00643169590984

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other SEE H10.