BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2851629 · Received November 29, 2012

    Report

    Report Number
    9673241-2012-00347
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4). REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4). EVENT DESCRIPTION CONTINUATION: THIS INCIDENT OCCURRED AT THE EXTREME END OF THE FIRST AND ONLY ABLATION. THE PATIENT WAS AWAKE AND COMPLAINED OF SEVERE CHEST PAIN. THE PHYSICIAN AND STAFF IMMEDIATELY CHECKED THE PATIENT'S BLOOD PRESSURE THROUGH THE ARTERIAL LINE. IT WAS LOW (IN THE 50'S MMHG). THE PHYSICIAN THEN CHECKED FLUOROSCOPY FOR THE LEFT HEART BORDER MOVEMENT AND HE DETERMINED THE PATIENT WAS IN TAMPONADE. HE IMMEDIATELY CALLED FOR BACKUP HELP IN THE ROOM AND STARTED AN EMERGENCY PERICARDIAL TAP. THE PATIENT REQUIRED CHEST COMPRESSIONS AND HAD A VERY LOW BLOOD PRESSURE FOR APPROXIMATELY 10 MINUTES. A HEART SURGEON AND ALL AVAILABLE CARDIOLOGISTS WERE CALLED INTO THE ROOM. THE PATIENT WAS RUSHED TO THE SURGICAL SUITE AND OPERATED ON. THE PERFORATION SITE WAS IMMEDIATELY DISCOVERED AND REPAIRED. THE PATIENT'S UPDATED HEALTH STATUS IS THAT AFTER SURGICAL INTERVENTION, THE PATIENT'S CONDITION IMPROVED AND HE AWOKE WITHOUT FURTHER COMPLICATION. THE EVENT WAS NOT ATTRIBUTED TO A TRANSSEPTAL PUNCTURE. THERE WAS NOTHING SPECIFIC ABOUT THE PATIENT'S ANATOMY THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE USER DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER BEFORE THE EVENT. A SHORT SHEATH WAS USED WITH THE NAVISTAR ELECTROPHYSIOLOGY CATHETER. THERE WERE NO REPROCESSED CATHETERS BEING USED IN THIS PROCEDURE. THE PATIENT DIDN'T RECEIVE ANY ANTICOAGULATION DURING THIS PROCEDURE. THIS WAS A RIGHT SIDED PROCEDURE. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THAT THE PERFORATION OCCURRED DUE TO THE "STEAM POP" THAT HE HEARD AT THE VERY END OF HIS ABLATION DURATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHILE PERFORMING AN FOCAL IDIOPATHIC VT ABLATION (RVOT PVC) PROCEDURE, THEY WERE ABLATING AT 40 WATTS AT 55 DEGREES AND INCREASING INCREMENTS WHEN THE PHYSICIAN HEARD A STEAM POP. THE PATIENT'S BLOOD PRESSURE WAS CHECKED AND IT WAS LOW. THE PATIENT COMPLAINED OF CHEST PAIN. A PERICARDIOCENTESIS WAS PERFORMED. AFTER 10 MINUTES OF CPR, THE PATIENT WAS TAKEN TO THE OR WITH A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PERFORATION. THE PATIENT WAS THEN IN STABLE CONDITION. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. A DEFLECTION TEST WAS ALSO PERFORMED AND THE CATHETER PASSED ALL THE TESTS. THE ROOT CAUSE OF THE STEAM POP AND PERFORATION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A FOCAL IDIOPATHIC VT ABLATION (RVOT PVC) PROCEDURE, THEY WERE ABLATING AT 40 WATTS AT 55 DEGREES AND INCREASING INCREMENTS WHEN THE PHYSICIAN HEARD A STEAM POP. THE PATIENT'S BLOOD PRESSURE WAS CHECKED AND IT WAS LOW. THE PATIENT COMPLAINED OF CHEST PAIN. A PERICARDIOCENTESIS WAS PERFORMED. AFTER 10 MINUTES OF CPR, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WITH A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PERFORATION. THE PATIENT WAS THEN IN STABLE CONDITION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN MADE A THOROUGH LAT MAP OF THE RVOT LOCALIZING THE SITE OF EARLIEST ACTIVATION TO THE POSTERIOR LATERAL PORTION OF THE RVOT. THE PHYSICIAN WAS HAPPY WITH THE SITE AND DECIDED TO ABLATE. THE STOCKERT 70 SYSTEM WAS SET TO "TEMPERATURE CONTROL" MODE. THE PHYSICIAN CAME ON ABLATION AT 55 DEGREES AND 40 WATTS. HE HAD THE TECHNICIAN GRADUALLY TITRATE UP THE POWER TO 45 WATTS. THE IMPEDANCE DECREASED GRADUALLY BY APPROXIMATELY 12 OHMS. THE PHYSICIAN SAID THAT HE WANTED TO STAY ON FOR 90 SECONDS. THEY WERE WATCHING THE ABLATION PARAMETERS CAREFULLY. AT 88 SECONDS IT WAS SAID ALOUD "WE ARE COMING OFF ABLATION" AND CAME OFF RIGHT AT 90 SECONDS. AS STAFF WAS PRESSING THE "STOP" BUTTON ON THE STOCKERT 70 SYSTEM, THE PHYSICIAN SAID "OFF, OFF" BECAUSE HE HEARD A "STEAM POP." SIMULTANEOUS TO THE STEAM POP, THERE WAS A SHARP RISE IN THE IMPEDANCE. THE IMPEDANCE RISE WAS ONLY SEEN AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1183-08-S 15635473M

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R