BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5136175 · Received October 8, 2015

    Report

    Report Number
    9673241-2015-00714
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4). CONCOMITANT PRODUCTS: 1.CARTO 3 SYSTEM. 2. SMARTABLATE GENERATOR. 3.SMARTABLATE PUMP. 4.LASSO NAV VARIABLE ECO CATHETER, MODEL #: D-1343-02-S, LOT #: 17233819L. 5.SOUNDSTAR ECO CATHETER, MODEL #: M-5723-17. (B)(4). EVENT DESCRIPTION CONTINUATION: THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE CARDIAC TAMPONADE WAS MOST LIKELY RELATED TO THE REPROCESSED STRYKER CORONARY SINUS CATHETER. HOWEVER, BIOSENSE WEBSTER INC. HAS MADE THE ASSESSMENT TO CONSERVATIVELY REPORT THIS EVENT UNDER OUR ABLATION CATHETER AS BIOSENSE WEBSTER INC. CATHETERS WERE ALSO USED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A FEMALE PATIENT WHICH WAS OVER 60 YEARS OLD, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. MID-WAY THROUGH THE PROCEDURE, THE PATIENT¿S PRESSURE DROPPED AND HEART RATE WENT UP. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE PROCEDURE WAS ABORTED AND THEY PERFORMED A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED AND FULLY RECOVERED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT MOST LIKELY OCCURRED WITH THE REPROCESSED (STRYKER) BIOSENSE WEBSTER INC. CORONARY SINUS CATHETER. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. THE FORCE FEATURE WAS EVALUATED AND PASSED. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. 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. THE ROOT CAUSE OF THE TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHICH WAS OVER 60 YEARS OLD, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. MID-WAY THROUGH THE PROCEDURE, THE PATIENT'S PRESSURE DROPPED AND HEART RATE WENT UP. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE PROCEDURE WAS ABORTED AND THEY PERFORMED A PERICARDIOCENTESIS. THE PERICARDIAL EFFUSION WAS NOTICED NEARLY 45 MINUTES AFTER THE TRANSSEPTAL PUNCTURE AND WELL AFTER THE ABLATION WAS PERFORMED. BOTH THE LEFT INFERIOR PULMONARY VEIN (LIPV) AND LEFT SUPERIOR PULMONARY VEIN (LSPV) HAD BEEN ISOLATED. THEY WERE ABLATING NEAR THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WHEN THE PERICARDIAL EFFUSION WAS NOTICED. THE LOCATION WHERE THEY THOUGHT THE PERICARDIAL EFFUSION OCCURRED WAS NOT NEAR WHERE THEY WERE ABLATING. THEREFORE, ABLATION AND CATHETERS IN THE LEFT ATRIUM WERE NOT THOUGHT TO HAVE CONTRIBUTED TO THIS EVENT. ANATOMY WAS NOT THOUGHT TO BE ABNORMAL. THE PATIENT STAYED OVERNIGHT AS WAS THE ORIGINAL PLAN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED AND FULLY RECOVERED. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT MOST LIKELY OCCURRED WITH THE REPROCESSED (STRYKER) BIOSENSE WEBSTER INC. CORONARY SINUS CATHETER. IT WAS THOUGHT THAT WHEN THEY REMOVED IT FROM THE CORONARY SINUS TO PACE FOR PHRENIC IN THE SUPERIOR VENA CAVA (SVC) AND THEN REINSERTED INTO THE CORONARY SINUS, IT MOST LIKELY CAUSED A DISSECTION OF THE CORONARY SINUS. THE PROCEDURE MOST LIKELY CONTRIBUTED TO THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667506 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17253726M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R