BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F

    MDR report key: 4130129 · Received September 30, 2014

    Report

    Report Number
    3005188751-2014-00115
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    PK061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00114. DURING A LEFT ATRIAL MAPPING PROCEDURE USING A BRK TRANSSEPTAL NEEDLE AND AN AGILIS NXT INTRODUCER, A CARDIAC PERFORATION OCCURRED. DURING THE CASE, THE PATIENT BECAME HYPOTENSIVE. AN ICE CATHETER CONFIRMED A LEFT ATRIAL PERFORATION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS THEN PREPPED FOR TRANSFER TO SURGERY. FURTHER INFORMATION WAS UNAVAILABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607915 AGILIS? NXT STEERABLE INTRODUCER DUAL-REACH? 71 CM SHEATH, MEDIUM CURL, 8.5 F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 408310 4572031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTO 3 MAPPING SYSTEM| BRK TRANSSEPTAL NEEDLE| STOCKERT GENERATOR| COOLFLOW PUMP| UNKNOWN BIOSENSE WEBSTER CATHETER