BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    MDR report key: 3152599 · Received June 5, 2013

    Report

    Report Number
    3005188751-2013-00064
    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
    K061015
    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 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 ASYSTOLE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MFG REFERENCE: 2030404-2013-00044, 3005188751-2013-00063, 2030404-2013-00045. DURING A LEFT SIDE ABLATION PROCEDURE FOR SYMPTOMATIC ATYPICAL ATRIAL FLUTTER, THE PATIENT EXPERIENCED AN EPISODE OF ASYSTOLE WITH UNKNOWN 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 PATIENT WAS IN ASYSTOLE. CHEST COMPRESSIONS WERE INITIATED AND UNSUCCESSFUL ATTEMPTS WERE MADE TO PACE THE PATIENT FROM THE INQUIRY CATHETER LOCATED IN THE CS. THE INQUIRY CATHETER WAS WITHDRAWN FROM THE CS AND PLACED IN THE RIGHT VENTRICLE (RV) TO SUCCESSFULLY PACE THE PATIENT. APPROXIMATELY 45 SECONDS LATER, A RECORDABLE HEART RATE RETURNED AND THE PATIENT CONVERTED TO SINUS RHYTHM TWO MINUTES 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 PATIENT'S CONDUCTION SYSTEM, WHICH REVEALED NO ABNORMALITIES. THE PROCEDURE WAS ABORTED AND THE PATIENT 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 ANY SJM DEVICE AND THE CAUSE FOR THE ASYSTOLE WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247878 FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 406840 3845778

    Patients

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