BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 12919259 · Received December 2, 2021

    Report

    Report Number
    9617601-2021-00182
    Event Type
    Death
    Date Received
    December 2, 2021
    Date of Event
    September 16, 2021
    Report Date
    December 2, 2021
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE PATIENT FILES SHOWED AT LEAST 11 APPLICATIONS WERE PERFORMED WITH BALLOON CATHETER WITHOUT ANY ISSUE ON THE DATE OF THE EVENT. IN CONCLUSION, THE REPORTED DEATH AND CLINICAL ISSUES FOR SEPSIS, STROKE, AND ATRIO-ESOPHAGEAL FISTULA COULD NOT BE CONFIRMED THROUGH ANALYSIS OF THE DATA FILES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE WEEKS POST-OPERATIVELY TO A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF SEPSIS. AN ATRIO-ESOPHAGEAL FISTULA WAS DISCOVERED AND SURGICAL INTERVENTION TOOK PLACE IN AN ATTEMPT TO REPAIR IT. THE PATIENT ALSO HAD A STROKE THAT WAS SEEN ON A COMPUTERIZED TOMOGRAPHY (CT) SHORTLY AFTER HOSPITAL ADMISSION. THE PATIENT WAS HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. TWO WEEKS AFTER THE INITIAL SEPSIS AND FISTULA ONSET, THE PATIENT PASSED AWAY. IT WAS DEEMED THAT THE ATRIO-ESOPHAGEAL FISTULA WAS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815248 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC MEXICO S. DE R.L. DE CV 990063-020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death AFAPRO28 BALLOON CATHETER, 4FC12 SHEATH