BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-CATH TRANSSEPTAL INTRODUCER, 8.5F, 60 CM

    MDR report key: 2153258 · Received June 30, 2011

    Report

    Report Number
    3005188751-2011-00108
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K920327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND MICROSCOPIC EXAMINATION REVEALED NO VISIBLE SURFACE ANOMALIES. FUNCTIONAL TESTING OF THE DEVICE REVEALED NO LEAKS. REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER REPORTS: 2030404-2011-00197, 2030404-2011-00196, 3005188751-2011-00110, 3005188751-2011-00109. IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A SJM BRK NEEDLE ALONG WITH A FAST-CATH TRANSSEPTAL INTRODUCER WAS USED TO GAIN ACCESS TO THE LEFT ATRIUM. A 6F INQUIRY STEERABLE CATHETER WAS INSERTED INTO THE SUPERIOR VENA CAVA TO MAP PHRENIC NERVE PACING STIMULATION PRIOR TO CRYO BALLOONING. A REFLEXION SPIRAL 7F CATHETER WAS USED TO CREATE LEFT ATRIAL GEOMETRY AND TO CHECK FOR PULMONARY VEIN POTENTIALS. THE STEERING WIRES ON THE DEVICE WERE NOTED TO BE BROKEN AFTER EXTENSIVE USE OF THE DEVICE. THE PHYSICIAN HAD SUCCESSFULLY ISOLATED ALL FOUR PULMONARY VEINS USING A LARGE MEDTRONIC ARCTIC FRONT CRYO BALLOON. DURING THE POST TESTING PHASE OF THE PROCEDURE AN ATRIAL TACHYCARDIA WAS INDUCED. THE ARCTIC FRONT CRYO BALLOON WAS REMOVED FROM THE LEFT ATRIUM AND A MEDIUM CURL COOL PATH WAS INSERTED VIA THE 15FR MEDTRONIC FLEX CATHETER SHEATH THAT WAS USED FOR THE BALLOON. IT WAS OBSERVED THAT THE MEDTRONIC FLEX CATHETER SHEATH HAD FALLEN BACK INTO THE RIGHT ATRIUM, HOWEVER THE COOL PATH WAS EASILY INSERTED INTO THE LEFT ATRIUM ALONE. WHEN THE PHYSICIAN TRIED TO ADVANCE THE FLEX CATHETER SHEATH OVER THE COOL PATH CATHETER, THERE WAS SOME RESISTANCE, BUT HE WAS ABLE TO ADVANCE IT INTO THE LEFT ATRIUM. MAPPING AND ABLATION OF THE TACHYCARDIA WAS PERFORMED ALONG THE MITRAL VALVE ISTHMUS REGION WHEN SHORTLY THEREAFTER, THE PATIENT'S BLOOD PRESSURE DROPPED. AN INTRACARDIAC ECHOCARDIOGRAM CONFIRMED A 2CM PERICARDIAL EFFUSION. THE CATHETERS WERE PULLED BACK AND A PERICARDIOCENTESIS WAS PERFORMED. PROTAMINE WAS ADMINISTERED FOLLOWED BY FRESH FROZEN PLASMA. THE PATIENT'S ACT WAS IN THE LOW 300'S PRIOR TO THE PROTAMINE ADMINISTRATION. THE PATIENT'S SYSTOLIC BLOOD PRESSURE RANGE WAS 90-100. THE PERICARDIAL ACCESS CLOTTED OFF AND THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE A PERICARDIAL WINDOW PROCEDURE WAS PERFORMED FOR FURTHER DRAINAGE OF THE EFFUSION. THE CURRENT STATUS OF THE PATIENT IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH TRANSSEPTAL INTRODUCER, 8.5F, 60 CM FAST-CATH TRANS, 8.5F DYB ST. JUDE MEDICAL, AF DIVISION 406804 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention