BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4241952 · Received November 10, 2014

    Report

    Report Number
    9673241-2014-00467
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY: (B)(4) IT WAS REPORTED THAT THE CARTO 3 SYSTEM DISPLAYED A DATA STREAMING ERROR WHEN THE ABLATION CATHETER WAS PLUGGED IN. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. LATER ON WHEN USING THE SECOND ABLATION CATHETER THE PATIENT EXPERIENCED A DROP IN BP AND A PERICARDIAL EFFUSION WAS DISCOVERED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS REPORTED STABLE. 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. A DEFLECTION TEST WAS ALSO PERFORMED AND CATHETER PASSED. FINALLY, THE FUNCTIONALITY OF THE BIOSENSOR CATHETER WAS TESTED ON CARTO SYSTEM. THE CATHETER FAILED DURING CARTO TEST, ERROR 106 WAS DISPLAYED. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. 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. CATHETER FAILED CARTO TEST. THE CUSTOMER COMPLAINT REGARDING A STREAMING ERROR HAS BEEN VERIFIED. HOWEVER THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE CONCOMITANT PRODUCTS: THE CARTO 3 SYSTEM (B)(4); STOCKERT 70 (B)(4); COOLFLOW PUMP (B)(4), LASSO CATHETER (B)(4) (LOT # 15505483LA) WAS USED IN THE PROCEDURE. AN ACUNAV REPROCESSED CATHETER WAS ALSO UTILIZED IN THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, THE CARTO 3 SYSTEM DISPLAYED A DATA STREAMING ERROR WHEN THE ABLATION CATHETER WAS PLUGGED IN. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. LATER ON WHEN USING THE SECOND ABLATION CATHETER THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND A PERICARDIAL EFFUSION WAS DISCOVERED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE AT THAT TIME. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS HIGH FORCE WITH MOVEMENT IN RIGHT INFERIOR VEIN. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT FOR OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723762 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S 17043781M

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R