BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 3152600 · Received June 5, 2013

    Report

    Report Number
    3005188751-2013-00063
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED ASYSTOLE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MFR REFERENCE: 2030404-2013-00044, 3005188751-2013-00064, 2030404-2013-00045. DURING A LEFT SIDE ABLATION PROCEDURE FOR SYMPTOMATIC ATYPICAL ATRIAL FLUTTER, THE PT EXPERIENCED AN EPISODE OF ASYSTOLE WITH UNK ORIGIN. THE PHYSICIAN PLACED AN INQUIRY STEERABLE DECAPOLAR CATHETER THROUGH A SHORT NON-SJM INTRODUCER INTO THE CORONARY SINUS (CS). A THERAPY COOL PATH ABLATION CATHETER WAS ADVANCED THROUGH AN AGILIS NXT INTRODUCER INTO THE LEFT ATRIUM VIA A PREVIOUS TRANSSEPTAL PUNCTURE. THE PHYSICIAN WAS PREPARING TO PERFORM A SECOND TRANSSEPTAL PUNCTURE USING A FAST CATH SWARTZ INTRODUCER WITH A NON-SJM TRANSSEPTAL NEEDLE WHEN HE NOTED THE PT WAS IN ASYSTOLE. CHEST COMPRESSIONS WERE INITIATED AND UNSUCCESSFUL ATTEMPTS WERE MADE TO PACE THE PT FROM THE INQUIRY CATHETER LOCATED IN THE OS. THE INQUIRY CATHETER WAS WITHDRAWN FROM THE CS AND PLACED IN THE RIGHT VENTRICLE (RV) TO SUCCESSFULLY PACE THE PT. APPROX 45 SECONDS LATER A RECORDABLE HEART RATE RETURNED AND THE PT CONVERTED TO SINUS RHYTHM TWO MINS AFTER EPINEPHRINE AND ATROPINE WERE ADMINISTERED. A RIGHT BUNDLE BRANCH BLOCK WAS NOTED AND AN ECHOCARDIOGRAM VIA NON-SJM ICE CATHETER REVEALED A VENTRICULAR WALL ABNORMALITY, WHICH COULD NOT BE FOUND POST-PROCEDURE. A CORONARY ANGIOGRAM WAS PERFORMED, REVEALING NO ABNORMALITIES; THEREFORE, NO INTERVENTION WAS ADMINISTERED. AN INQUIRY QUADRIPOLAR CATHETER WAS INSERTED TO ASSIST WITH AN EP STUDY TO ASSESS THE PT'S CONDUCTION SYSTEM, WHICH REVEALED NO ABNORMALITIES. THE PROCEDURE WAS ABORTED AND THE PT WAS TRANSFERRED TO CRITICAL CARE. NO ABLATION WAS PERFORMED OR GEOMETRY CREATED PRIOR TO THE PERIOD OF ASYSTOLE. THE PHYSICIAN DID NOT ALLEGE ANY PERFORMANCE ISSUES WITH A SJM DEVICE AND THE CAUSE FOR THE ASYSTOLE WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247865 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 408310 4004749

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention VELOCITY MAPPING SYSTEM| INQUIRY STEERABLE CATHETER ((B)(4))| FAST CATH SWARTZ INTRODUCER ((B)(4))| THERAPY COOL PATH CATHETER ((B)(4))| BAYLIS TRANSSEPTAL NEEDLE ((B)(4))| CORDIS SHORT INTRODUCER| BRK TRANSSEPTAL NEEDLE ((B)(4))