BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS INTRODUCER, UNKNOWN

    MDR report key: 2975848 · Received June 5, 2008

    Report

    Report Number
    2182269-2008-00394
    Event Type
    Injury
    Date Received
    June 5, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGILIS DEVICE WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, THE CAUSE FOR THE REPORTED PERFORATION REMAINS UNKNOWN. IT SHOULD BE NOTED DR (B)(6) DOES NOT BELIEVE THE INJURY WAS CAUSED BY THE NAVX PATCH, ENSITE SYSTEM NOR THE AGILIS SHEATH.

    Description of Event or Problem · 1

    AN AGILIS SHEATH WAS ONE OF TWO TRANSSEPTAL SHEATHS USED IN THE ATRIAL FIBRILLATION ABLATION. A BIOSENSE WEBSTER LASSO WAS USED IN THE LEFT ATRIUM ALONG WITH A COOL PATH CATHETER. THE ENSITE SYSTEM WAS USED FOR NAVIGATION IN CONJUNCTION WITH A NAVX PATCH. AFTER COMPLETING THE ABLATION, IT WAS NOTED THAT A PERICARDIAL EFFUSION WAS PRESENT. A CARDIOLOGIST WAS CONTACTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN REPORTED THAT OVER 500 ML OF FLUID WAS WITHDRAWN FROM THE PERICARDIUM IN THE LAB. THE PIGTAIL WAS LEFT IN THE PT OVERNIGHT WITHOUT ANY ADDITIONAL DRAINAGE. THE PT REMAINED STABLE THROUGHOUT. THE PT DID NOT EXHIBIT ANY ADDITIONAL PROBLEMS AS A RESULT OF THE INJURY. THE PHYSICIAN DOES NOT BELIEVE THE INJURY WAS CAUSED BY THE NAVX PATCH, ENSITE SYSTEM NOR THE AGILIS SHEATH. THE CAUSE FOR THE PERFORATION COULD NOT BE DETERMINED. NO LOT NUMBERS ARE AVAILABLE FOR THE BIOSENSE WEBSTER LASSO OR COOL PATH CATHETERS. NO SERIAL OR LOT NUMBERS WERE PROVIDED FOR THE ENSITE SYSTEM OR THE NAVX PATCH. THE ENSITE SYSTEM WAS FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS INTRODUCER, UNKNOWN AGILIS INTRODUCER, UNK. OEX ST. JUDE MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other