BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3160192 · Received June 10, 2013

    Report

    Report Number
    9673241-2013-00182
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4). STOCKERT MODEL# M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP MODEL# M-5491-02, SERIAL # (B)(4). LASSO MODEL# D-1220-39-S, LOT# UNKNOWN. CUSTOMER DISPOSED OF (B)(4) ARE RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AFTER AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A PERICARDIAL EFFUSION POST AF ABLATION VIA TRANSTHORACIC ECHOCARDIOGRAM. THE EFFUSION IS BEING ATTRIBUTED TO HAVING TO ABANDON THE USE OF CARTO3 DUE TO AN ERROR 8. THE CALLER REPORTED THAT THE ERROR WAS DISPLAYED WHEN THE NAVISTAR WAS CONNECTED. NO PACING WAS BEING PERFORMED. THE CATHETERS WERE DISCONNECTED AND THE PIU WAS REBOOTED. THE PIU INITIALIZED NORMALLY AND THE CATHETERS WERE INTRODUCED ONE AT A TIME. WHEN THE NAVISTAR WAS CONNECTED WITH A NEW CABLE THE ERROR REPEATED. THE CATHETERS WERE DISCONNECTED AND THE PIU WAS REBOOTED AGAIN AND STARTED NORMALLY. A DIFFERENT NAVISTAR (DIFFERENT LOT NUMBER) WAS CONNECTED TO THE PIU FIRST. ERROR 1201 WAS BRIEFLY DISPLAYED THEN ERROR 8 RETURNED. THE NAVISTAR WAS DISCONNECTED AND THE PIU WAS REBOOTED ONCE AGAIN WITH A DIFFERENT 12-LEAD CABLE CONNECTED. WHEN THE NAVISTAR WAS CONNECTED THE ERROR 8 RETURNED. AT THIS POINT THE PHYSICIAN ELECTED TO BYPASS CARTO 3 AND CONTINUED THE CASE WITH A CELSIUS CATHETER. AT THE TIME OF THE CALL THE PATIENT WAS STABLE, BUT BEING BROUGHT BACK TO THE LAB FOR A PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) 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. THE CATHETER PASSED ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A PERICARDIAL EFFUSION POST AF ABLATION VIA TRANSTHORACIC ECHOCARDIOGRAM. THE EFFUSION IS BEING ATTRIBUTED TO HAVING TO ABANDON THE USE OF CARTO3 DUE TO AN ERROR 8. THE CALLER REPORTED THAT THE ERROR WAS DISPLAYED WHEN THE NAVISTAR WAS CONNECTED. NO PACING WAS BEING PERFORMED. THE CATHETERS WERE DISCONNECTED AND THE PIU WAS REBOOTED. THE PIU INITIALIZED NORMALLY AND THE CATHETERS WERE INTRODUCED ONE AT A TIME. WHEN THE NAVISTAR WAS CONNECTED WITH A NEW CABLE THE ERROR REPEATED. THE CATHETERS WERE DISCONNECTED AND THE PIU WAS REBOOTED AGAIN AND STARTED NORMALLY. A DIFFERENT NAVISTAR (DIFFERENT LOT NUMBER) WAS CONNECTED TO THE PIU FIRST. ERROR 1201 WAS BRIEFLY DISPLAYED THEN ERROR 8 RETURNED. THE NAVISTAR WAS DISCONNECTED AND THE PIU WAS REBOOTED ONCE AGAIN WITH A DIFFERENT 12-LEAD CABLE CONNECTED. WHEN THE NAVISTAR WAS CONNECTED THE ERROR 8 RETURNED. AT THIS POINT THE PHYSICIAN ELECTED TO BYPASS CARTO 3 AND CONTINUED THE CASE WITH A CELSIUS CATHETER. AT THE TIME OF THE CALL THE PATIENT WAS STABLE, BUT BEING BROUGHT BACK TO THE LAB FOR A PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260379 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15750720L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R