BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8251213 · Received January 15, 2019

    Report

    Report Number
    2029046-2019-02573
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    December 18, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. DURING THE PROCEDURE, THE PATIENT HAD BEEN COMPLAINING OF PAIN WITH RADIO FREQUENCY DELIVERY, BUT IT WASN'T UNTIL THE END OF THE PROCEDURE THAT THE PATIENT'S BLOOD PRESSURE DECREASED AND DEVELOPED SHORTNESS OF BREATH. DURING ONE OF THE LAST RADIO FREQUENCY APPLICATIONS ON THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PREMATURE VENTRICULAR CONTRACTIONS (PVC¿S), ALONG THE ANTEROLATERAL RIGHT VENTRICLE WALL, THE PATIENT SUFFERED CARDIAC TAMPONADE. THE CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO. THE PATIENT WAS INTUBATED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS STABILIZED AND EXTUBATED AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PATIENT¿S OUTCOME IS IMPROVED. THE DEVICE WAS VISUALLY INSPECTED AND CHAR WAS OBSERVED ON THE TIP. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR WAS TESTED AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, 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. THEN, THE IRRIGATION AND DEFLECTION TEST WERE PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. 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 ADVERSE EVENT REMAINS UNKNOWN. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT POSSIBLY OCCURRED WHEN ZEROING THE CATHETER WHEN PASSING THE PULMONARY VALVE AND MISTAKEN THE SIGNAL IN THAT AREA FOR FREE FLOATING. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC EQUIPMENT. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. CHAR IS A PHYSICAL PHENOMENON OF RADIO FREQUENCY. IT CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS; HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. MANUFACTURER¿S REFERENCE NUMBER: (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. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30104339L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. ON JANUARY 15, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT. THE RETURN CONDITION WAS THE PRODUCT HAD REDDISH-BLACK MATERIAL ON CATHETER TIP. ACCORDING TO PRODUCT ANALYSIS LAB ANALYSIS, THE SUBSTANCE ON THE CATHETER IS CHAR. THE PRESENCE OF CHAR, THROMBUS, OR CLOT ON THE ELECTRODES DO NOT REPRESENT A SERIOUS INJURY IN ITSELF NOR IS NECESSARILY THE RESULT OF DEVICE MALFUNCTION. THIS RETURN CONDITION HAS BEEN ASSESSED AS NOT REPORTABLE. THERE IS NO RISK TO THE PATIENT. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC PRODUCT - ST. JUDE MEDICAL - AGILIS MEDIUM CURVE SHEATH BIOSENSE WEBSTER, INC. PRODUCT - SMARTABLATE GENERATOR, CATALOG #: UNKNOWN, SERIAL #: UNKNOWN; BIOSENSE WEBSTER, INC. PRODUCT - CARTO® 3 SYSTEM, CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT HAD BEEN COMPLAINING OF PAIN WITH RADIO FREQUENCY DELIVERY, BUT IT WASN'T UNTIL THE END OF THE PROCEDURE THAT THE PATIENT'S BLOOD PRESSURE DECREASED AND DEVELOPED SHORTNESS OF BREATH. DURING ONE OF THE LAST RADIO FREQUENCY APPLICATIONS ON THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) PREMATURE VENTRICULAR CONTRACTIONS (PVC¿S), ALONG THE ANTEROLATERAL RIGHT VENTRICLE WALL, THE PATIENT SUFFERED CARDIAC TAMPONADE. THE CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO. THE PATIENT WAS INTUBATED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 200 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS STABILIZED AND EXTUBATED AFTER PERICARDIAL DRAINAGE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT POSSIBLY OCCURRED WHEN ZEROING THE CATHETER WHEN PASSING THE PULMONARY VALVE AND MISTAKEN THE SIGNAL IN THAT AREA FOR FREE FLOATING. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. AN AGILIS MEDIUM CURVE SHEATH WAS USED. THE SMARTABLATE GENERATOR WAS USED WITHIN STANDARD SETTINGS FOR THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, PRE AND POST IRRIGATION, 50 WATTS AND 10 SECONDS. THE PATIENT DID NOT RECEIVE ANTICOAGULANT DURING THE PROCEDURE. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER AND IT WAS ZEROED POST WARM UP. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43147 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30104339L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R