BEUDAMED
    FDA Adverse Event Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL

    MDR report key: 2222738 · Received July 28, 2011

    Report

    Report Number
    3005188751-2011-00131
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE 8.5F AGILIS INTRODUCER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE STOPCOCK WAS CRACKED IN HANDLE VALVE AREA. MICROSCOPIC EXAMINATION OF THE STOPCOCK REVEALED A SERIES OF STRESS FRACTURES IN THE HANDLE VALVE AREA OF THE STOPCOCK. THE STRESS FRACTURES CAUSED THE REPORTED LEAK. THERE WAS NO DAMAGE OBSERVED ON THE THREADED AREAS OF THE STOPCOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE A LEAK OCCURRED. WHILE ATTEMPTING TO FLUSH THE SHEATH, THE SYRINGE WAS ADVANCED AND THEN WITHDRAWN WHEN AIR WAS NOTED AT THE PORT OF THE 3 WAY STOPCOCK. THE SHEATH WAS REPLACED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL AGILIS NXT, 8.5F DYB ST. JUDE MEDICAL, AF DIVISION 408309 3316193

    Patients

    Seq Age Sex Outcome Treatment
    1