BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2555572 · Received May 1, 2012

    Report

    Report Number
    2029046-2012-00057
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION AS INITIALLY REPORTED. ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN REGARDING THE EVENT ON (B)(6) 2012. THE PATIENT HAD PREVIOUSLY UNDERGONE EXTENSIVE LEFT ATRIAL ABLATION FOR PERSISTENT AF 15 MONTHS AGO AND HAD MAINTAINED SINUS RHYTHM THE MAJORITY OF THE TIME AFTER THIS SINGLE PROCEDURE (80 MINUTES OF RF WITH THERMOCOOL INCLUDING ANTRAL PULMONARY VEIN ISOLATION, CFE ABLATION EXTENSIVELY IN THE LEFT ATRIUM AND CORONARY SINUS AS WELL AS LINEAR ABLATION ALONG THE ROOF AND MITRAL ISTHMUS). HE DID HOWEVER SUFFER FROM RECURRENT ATYPICAL LEFT ATRIAL TACHYCARDIA. THIS PROCEDURE TARGETED THIS ARRHYTHMIA SPECIFICALLY AS HE HAD NOT HAD RECURRENT AF. IT WAS PERFORMED INTENTIONALLY WITH A THERAPEUTIC INR OF 2.1. DOUBLE TRANSSEPTAL PUNCTURE WAS PERFORMED AND HE WAS HEPARINIZED TO AN ACT OF 350 SECONDS. ACTIVATION MAPPING WITH CARTO3 DEMONSTRATED A FOCAL (LIKELY REENTRANT) ATRIAL TACHYCARDIA AT THE ANTERIOR/SUPERIOR ASPECT OF THE LEFT ATRIAL APPENDAGE, A SITE OF PRIOR CFE ABLATION. THIS WAS SUCCESSFULLY ABLATED AND TERMINATED WITH TWO TO THREE MINUTES OF RF AT 30 WATTS POWER. A SECOND FOCAL ATRIAL TACHYCARDIA RESULTED WITH TERMINATION OF THE FIRST AT. THIS WAS MAPPED TO MITRAL ANNULUS REGION AT THE ENDOCARDIAL ASPECT OF THE LIGAMENT OF MARSHALL. RF WAS DELIVERED ENDOCARDIALLY INITIALLY AT 35 WATTS AND THEN (VERY BRIEFLY) 40 WATTS POWER. ABLATION WAS FOR PERHAPS 2-3 MINUTES AT 35 WATTS BEFORE INCREASING THE POWER. THERE WAS NO CHANGE IN IMPEDANCE AND NOT AUDIBLE STEAM POP. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS AN IMMEDIATE DECREASE IN SBP FROM 110 TO 55 MMHG. TAMPONADE WAS IMMEDIATELY IDENTIFIED AND EMERGENT PERICARDIOCENTESIS WAS PERFORMED. HEPARINIZATION WAS REVERSED IMMEDIATELY. THE PATIENT WAS STABILIZED QUICKLY BUT AFTER MORE THAN 2 LITERS OF FRANK BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE IT WAS DECIDED SURGICAL REPAIR WAS REQUIRED. IT WAS OBSERVED IN THE OR A RATHER LARGE HOLE (IT LOOKED LIKE THE EXIT WOUND OF A GUNSHOT TO TELL THE TRUTH) AT THE EXACT SPOT OF OUR SECOND (AND LAST) RF APPLICATION. THE PERFORATION WAS REPAIRED (ON CP BYPASS). HE PROGRESSED VERY QUICKLY AND WAS DISCHARGED APPROX 3 DAYS POST PROCEDURE. IN RETROSPECT A STEAM POP IS THE ONLY THING THAT MAKES SENSE AS THE CAUSATIVE MECHANISM. THE CATHETER TIP WAS PARALLEL RATHER THAN PERPENDICULAR TO THE ENDOCARDIAL BORDER AND THE CATHETER WAS WITHDRAWN (RATHER THAN DIRECTLY ADVANCED) TO THE DESIRED AREA OF ABLATION WHERE THE PERFORATION OCCURRED (IN OTHER WORDS I FIND IT UNLIKELY THAT THIS WAS CAUSED BY A MECHANICAL TRAUMA). DURING THE PROCEDURE I NOTED NO ABNORMALITY IN THE RF GENERATOR OR CATHETER'S PERFORMANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE MADE WITHOUT SUCCESS. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: US CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: US CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP: US CATALOG #: S7001, SERIAL #: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED SURGICAL INTERVENTION. THE EZ STEER CATHETER WAS IN USE DURING THE SURGERY AT THE TIME OF THE EVENT WAS REPORTED. THE CATALOG AND LOT NUMBERS WERE NOT AVAILABLE AS THEY HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1318-03-S UNKNOWN_D-1318-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R