BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3024181 · Received March 27, 2013

    Report

    Report Number
    2029046-2013-00045
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 28, 2013
    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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4); STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4); COOLFLOW PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4); DISTRIBUTED PRODUCT: ACUNAV CATHETER: MODEL #: M-5723-09, LOT #: OEM_M-5723-09, PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS; WEBSTER 10 POLE CATHETER: MODEL #: D-1086-587-S, LOT #: UNKNOWN_D-1086-587-S, PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS; LASSO NAVIGATIONAL VARIABLE ECO CATHETER: MODEL #: D-1343-01-S, LOT #: UNKNOWN_D-1343-01-S, PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS; WEBSTER 4 POOL WITH AUTO ID CATHETER: MODEL #: D-1079-260-S, LOT #: UNKNOWN_D-1079-260-S, PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. 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: THE PHYSICIAN CHECKED THE PATIENT'S HEART WITH THE ACUNAV CATHETER AND VISUALIZED AN EFFUSION. THE ABLATION WAS ABORTED AT THIS POINT. A PERICARDIOCENTESIS WAS PERFORMED IN THE EP LAB. THE EFFUSION CONTINUED AND THE PHYSICIAN CONSULTED WITH THE OR SURGEON. THE PATIENT WAS TRANSPORTED TO THE OR. THE EP PHYSICIAN SAID THAT PATIENT WAS STABLE POST SURGERY. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER AND DID NOT NOTICE ANY ABNORMAL SIGNALS. IT WAS UNKNOWN HOW MANY ABLATIONS THE PATIENT RECEIVED BEFORE THE EVENT. THE ACT WAS MAINTAINED AT 300-350S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. A DROP IN BLOOD PRESSURE WAS NOTICED BY THE ANESTHESIOLOGIST AND PHYSICIAN AS THEY WERE ATTEMPTING TO ABLATE THE LEFT INFERIOR PULMONARY VEIN (LIPV), AFTER ABLATING THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PHYSICIAN NOTICED AN EFFUSION ON INTRACARDIAC ECHO AND HE ABORTED THE ABLATION AT THAT POINT. A PERICARDIOCENTESIS WAS PERFORMED IN THE LAB. THE PATIENT WAS THEN SENT TO SURGERY. IT IS BELIEVED THE PATIENT WAS STABLE AFTER SURGERY. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. AFTER THE TRANSEPTAL PUNCTURES AND LEFT ATRIUM ACCESS, THE PHYSICIAN CREATED A FAST ANATOMICAL MAP (FAM) OF THE LEFT ATRUIM (LA) USING THE LASSO ECO NAVIGATIONAL CATHETER AS WELL AS WITH THERMOCOOL SF CATHETER. AFTER THE MAP WAS EDITED, THE PHYSICIAN BEGAN TO ABLATE STARTING WITH THE LSPV. THE RF GENERATOR WAS SET TO POWER CONTROL MODE AT 35 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS SET TO 50 DEGREES CELSIUS. THE FLOW SETTING WAS SET TO 15ML/MIN HIGH FLOW, 8ML/MIN LOW FLOW, 2ML/MIN MAPPING. THE ABLATION LINE STARTED IN THE ANTERIOR OUTSIDE OF THE LSPV AND CONTINUED INFERIOR TO THE LIPV. THE ABLATION CATHETER WAS POSITIONED INFERIOR TO THE LIPV AND THE PHYSICIAN ASKED THE ANESTHESIOLOGIST TO INSERT AN ESOPHAGEAL TEMPERATURE PROBE TO MONITOR TEMPERATURE ON THE POSTERIOR WALL OF THE LA IN RELATION TO ESOPHAGUS. THE ANESTHESIOLOGIST REPLIED THAT HE WILL AS SOON AS HE CAN TAKE CARE OF PATIENT'S BLOOD PRESSURE. PHYSICIAN ASKED WHAT WAS WRONG WITH PATIENT'S PRESSURE AND THE ANESTHESIOLOGIST REPLIED THAT PATIENT¿S PRESSURE WAS DROPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125805 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 80 YR Hospitalization| L| R