BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS? NXT STEERABLE INTRODUCER

    MDR report key: 4310053 · Received December 9, 2014

    Report

    Report Number
    3005188751-2014-00143
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    PK061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER OF THE DEVICE WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED TISSUE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING AN AGILIS NXT INTRODUCER, PATIENT TISSUE WAS ADHERED TO THE INTRODUCER UPON REMOVAL. DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE INVOLVING A PATIENT WITH DIFFICULT ANATOMY, THE PHYSICIAN HAD DIFFICULTY MANEUVERING THE AGILIS NXT INTRODUCER AND BENDS WERE NOTED IN THE SHAFT OF THE AGILIS NXT INTRODUCER. THE INTRODUCER REMAINED FUNCTIONING PROPERLY AND THE CASE WAS COMPLETED WITHOUT COMPLICATION. POST PROCEDURE, DURING REMOVAL OF THE AGILIS NXT INTRODUCER, TISSUE WAS ADHERED TO THE SHAFT OF THE AGILIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. THE PATIENT WAS MONITORED AN EXTRA DAY IN THE HOSPITAL AND WAS DISCHARGED WITHOUT COMPLICATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICES INVOLVED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796199 AGILIS? NXT STEERABLE INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC. 408310

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization BIOSENSE WEBSTER ACCUSON ICE| BARD STEERABLE DYNAMIC DECA CATHETER| BARD STEERABLE QUAD CATHETER| FAST CATH SWARTZ SL TRASSEPTAL INTRODUCER| REFLEXION SPIRAL CATHETER| BIOSENSE WEBSTER THERMOCOOL CELCIUS CATHETER| BRK TRANSSEPTAL NEEDLE