BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9471117 · Received December 15, 2019

    Report

    Report Number
    2029046-2019-03999
    Event Type
    Injury
    Date Received
    December 15, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE INVESTIGATIONAL ANALYSIS COMPLETED ON 12/20/2019. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR, TEMPERATURE AND FORCE FEATURES WERE TESTED. NO ISSUES WERE OBSERVED. DEFLECTION TESTING WAS PERFORMED AND THE CATHETER WAS DEFLECTING CORRECTLY. DURING IRRIGATION TESTING, THE CATHETER WAS OBSERVED OCCLUDED THEN, THE CATHETER WAS DISSECTED ON THE DOME AND REDDISH MATERIAL WAS FOUND OCCLUDING THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE ROOT CAUSE OF THE REDDISH MATERIAL INSIDE THE DOME COULD BE RELATED TO THE PROCEDURE. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING AN INTERVAL REVIEW ON 12/15/2019 , IT WAS NOTICED THAT THE INITIAL VISUAL INSPECTION WAS OMITTED FROM THE INITIAL REPORT IN ERROR. THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL VISUAL INSPECTION, NO DAMAGE OR ANOMALIES WERE OBSERVED. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. UPON INITIAL INSPECTION, NO DAMAGE OR ANOMALIES WERE OBSERVED. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. UPON INITIAL INSPECTION, NO DAMAGE OR ANOMALIES WERE OBSERVED. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE, A CARDIAC TAMPONADE WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAM AND ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND 820 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. EXTENDED HOSPITALIZATION WAS REQUIRED TO MONITOR FOR ANY ADDITIONAL FLUID BUILDUP. THE PATIENT¿S CONDITION IMPROVED, AND A FULLY RECOVERY IS EXPECTED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THE STSF CATHETER WENT THROUGH THE POSTERIOR FLOOR OF THE RIGHT ATRIUM WHILE TRYING TO ACCESS THE CORONARY SINUS. THIS WAS DONE PRIOR TO ZEROING THE CATHETER. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS NEEDLE AND BAYLIS SHEATH. ABLATION WAS PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. THERE IS NO EVIDENCE OF STEAM POP. FLOW SETTING DURING THE EVENT WAS 2ML. VISITAG PARAMETERS WERE RANGE 2MM FOR 3 SECONDS, FORCE OVER TIME 25% FOR 3 GRAMS, SURPOINT COLOR OPTION. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265770 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30276849M 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R BAYLISS SHEATH| BAYLISS TRANSSEPTAL NEEDLE| CARTO 3 SYSTEM