BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8253851 · Received January 16, 2019

    Report

    Report Number
    2029046-2019-02579
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 19, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION WAS OMITTED FROM THE INITIAL 3500A REPORT, THEREFORE THE FOLLOWING CORRECTION IS BEING SUBMITTED. PATIENT CODE OF ¿NO CODE AVAILABLE¿ REPRESENTS ¿SURGICAL INTERVENTION. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, MEDICATION AND SURGICAL INTERVENTION. DURING THE PROCEDURE, THERE WERE MOTOR ERRORS, INSUFFICIENT FLOW ERRORS BEING DISPLAYED ON THE SMARTABLATE PUMP. WHEN THE TUBING WAS REMOVED, IT WAS PINCHED WHERE IT WAS CLAMPED INTO THE PUMP. THE TUBING WAS MOVED BUT BECAME PINCHED AGAIN. THE CASE WAS CONTINUED BUT THE ISSUES REMAINED UNRESOLVED. THERE WAS NO EFFUSION DOCUMENTED ON TRANSTHORACIC ECHO (TEE) REPORT AT BEGINNING OF PROCEDURE. THEN DIAGNOSTIC CATHETERS WERE PLACED (ST. JUDE DUODECA AND 3 QUADS), THEN A ST. JUDE INTRACARDIAC ECHO (ICE) CATHETER WAS PLACED. THE PHYSICIAN DIAGNOSED A PERICARDIAL EFFUSION CONFIRMED BY ICE. DURING THE ABLATION, THE ANESTHESIOLOGIST REPORTED A DROP-IN PATIENT¿S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 300 CC OF FLUID FROM THE PERICARDIUM. VASOPRESSOR MEDICATION WAS ADMINISTERED. THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE OPERATING ROOM (OR) TO HAVE SURGERY. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. 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. 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. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE # (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 30100878L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. ON JANUARY 10, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT AND IT WAS OBSERVED THAT THERE WAS NO PHYSICAL DAMAGE UPON INITIAL VISUAL INSPECTION. CONCOMITANT PRODUCTS: NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - VIEWFLEX¿ XTRA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - BRK 1 XS TRANSSEPTAL NEEDLE. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - AGILIS SHEATH. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - DUODECA CATHETER. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - QUAD CATHETER (3 DEVICES). BIOSENSE WEBSTER, INC. - SMARTABLATE PUMP, CATALOG #: M-4900-08, SERIAL #: (B)(4). 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 MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, MEDICATION AND SURGICAL INTERVENTION. DURING THE PROCEDURE, THERE WERE MOTOR ERRORS, INSUFFICIENT FLOW ERRORS BEING DISPLAYED ON THE SMARTABLATE PUMP. WHEN THE TUBING WAS REMOVED, IT WAS PINCHED WHERE IT WAS CLAMPED INTO THE PUMP. THE TUBING WAS MOVED BUT BECAME PINCHED AGAIN. THE CASE WAS CONTINUED BUT THE ISSUES REMAINED UNRESOLVED. THERE WAS NO EFFUSION DOCUMENTED ON TRANSTHORACIC ECHO (TEE) REPORT AT BEGINNING OF PROCEDURE. THEN DIAGNOSTIC CATHETERS WERE PLACED (ST. JUDE DUODECA AND 3 QUADS), THEN A ST. JUDE INTRACARDIAC ECHO (ICE) CATHETER WAS PLACED. THE PHYSICIAN DIAGNOSED A PERICARDIAL EFFUSION CONFIRMED BY ICE. DURING THE ABLATION, THE ANESTHESIOLOGIST REPORTED A DROP-IN PATIENT¿S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 300 CC OF FLUID FROM THE PERICARDIUM. VASOPRESSOR MEDICATION WAS ADMINISTERED. THE PATIENT STABILIZED AND WAS TRANSFERRED TO THE OPERATING ROOM (OR) TO HAVE SURGERY. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS UNKNOWN; HOWEVER, HE DID NOT RELATE THE CAUSALITY OF THE EVENT TO THE PUMP ISSUE OCCURRED AT THE BEGINNING OF THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK 1 XS TRANSSEPTAL NEEDLE. A ST. JUDE MEDICAL AGILIS SHEATH WAS USED DURING THE PROCEDURE. THE PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING TRANSSEPTAL PHASE. THE ACTIVATED CLOTTING TIME (ACT) IS UNKNOWN. THE ABLATION PARAMETERS INCLUDED: 50 WATTS FOR 6 SECONDS EACH, FLOW RATE 15 ML/MIN. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). THE CARTO 3 DID NOT INDICATE TO RE-ZERO THE CATHETER. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THE ROTOR MECHANISM PROBLEM WAS ASSESSED AS NOT REPORTABLE. A PUMP MOTOR ROTATION FAILURE CAUSED BY LOW IRRIGATION FLOW WOULD MOST LIKELY CAUSE AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IS REMOTE. FURTHER, THIS ISSUE IS HIGHLY DETECTABLE WHEN OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47615 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30100878L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R