BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 2120247 · Received June 7, 2011

    Report

    Report Number
    3005188751-2011-00090
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE MANEUVERING THE CATHETER AND SHEATH IN THE LEFT ATRIUM, THE PATIENT'S PRESSURE DROPPED AND A PERFORATION WAS NOTED. THE PATIENT WAS TAKEN TO SURGERY. A NON ST JUDE MEDICAL IRRIGATED BI-DIRECTIONAL CATHETER AND THE AGILIS INTRODUCER WERE USED TO MAKE POINT BY POINT GEOMETRY OF THE LEFT ATRIUM. THIRTY MINUTES AFTER TRANSSEPTAL PUNCTURE, THE PATIENT HAD MILD LEFT ATRIAL ENLARGEMENT. A PERFORATION OF THE LEFT ATRIUM OCCURRED AND THE PATIENT WENT FOR EMERGENT SURGERY. THE PHYSICIAN STATED HE COULD SEE THE IRREGULARITY OF THE SHEATH ON FLUOROSCOPY, SHEATH CONTROL WAS POOR AND HE WAS GETTING READY TO REPLACE IT WITH ANOTHER AGILIS INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL AGILIS NXT, 8.5F MED CRL DYB ST. JUDE MEDICAL, AF DIVISION 408310 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THERMO COOL CATHETER: REORDER AND LOT UNKNOWN