BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 8520390 · Received April 16, 2019

    Report

    Report Number
    3032391-2019-00008
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 16, 2019
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    DYB
    UDI-DI
    10841898120275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A REPROCESSED ST. JUDE MEDICAL'S AGILIS NXT STEERABLE INTRODUCER, 22.4MM CURL DIMENSION 8.5FR X 71CM, BROKE DURING AN ABLATION. PER REPORT, THE PATIENT WENT INTO CARDIAC TAMPONADE AND THE PHYSICIAN DRAINED THE ACCUMULATED FLUIDS. IT WAS ADDED THAT THE PHYSICIAN IS CONCERNED THAT THE "BLUNT PORTION IS TOO BLUNT" AND THAT DIFFICULTY WAS ENCOUNTERED WHEN CROSSING THE SEPTUM. DUE TO THE REPORTED EVENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE DEVICE USED FOR THE PROCEDURE WAS RETURNED TO INNOVATIVE HEALTH (REPROCESSOR OF ELECTROPHYSIOLOGY CATHETER DEVICES FOR MEDLINE RENEWAL) FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE DEVICE FUNCTIONED AS EXPECTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPROCESSED AGILIS NXT STEERABLE INTRODUCER BROKE DURING AN ABLATION AND PATIENT DEVELOPED CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310191 ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER 22.4MM CURL DIMENSION 8.5FR X 71CM DYB MEDLINE RENEWAL UNK 10841898120275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R