BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8527349 · Received April 18, 2019

    Report

    Report Number
    2029046-2019-03005
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 27, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 4/19/2019. INITIAL VISUAL ANALYSIS OBSERVED NO DAMAGE OR ANOMALIES ON THE CATHETER. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CORRECTION: MANUFACTURER ADDRESS STREET LINE 1 IS BEING CORRECTED FROM 31 TECHNOLOGY DRIVE TO 33 TECHNOLOGY DRIVE.   MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/24/2019, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT AND THE PATIENT. IT WAS REPORTED THE PATIENT WAS A 49-YEAR-OLD-FEMALE. AFTER THE INTERVENTIONS OF PERICARDIOCENTESIS AND THORACOTOMY PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER THE INTERVENTIONS OF PERICARDIOCENTESIS AND THORACOTOMY PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THE FORCE SENSOR WAS TESTED AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. IRRIGATION AND DEFLECTION TEST WERE PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30130768L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. CONCOMITANT BWI PRODUCTS: SOUNDSTAR ECO CATHETER (US CATALOG # 10439011; LOT # E8148198); LASSO NAV ECO CATHETER (US CATALOG # D134901; LOT # 30116515L); EZ STEER CORONARY SINUS CATHETER (US CATALOG # BD710DF282RTS; LOT # 30114282M). INITIAL REPORTER PHONE: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PATIENT COMPLAINED ABOUT DISCOMFORT AFTER TRANSSEPTAL PUNCTURE. THE PROCEDURE CONTINUED, AND THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM. AT THIS POINT, CARDIAC TAMPONADE WAS CONFIRMED BY THE BODY SURFACE AND INTRACARDIAC ECHO (ICE). REMINDER OF THE PROCEDURE WAS ABORTED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN TRANSFERRED TO SURGERY, AND A THORACOTOMY WAS PERFORMED. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME OR PHYSICIAN CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319482 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30130768L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R