BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 8446645 · Received March 23, 2019

    Report

    Report Number
    2029046-2019-02870
    Event Type
    Injury
    Date Received
    March 23, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 1, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835003161
    PMA / PMN Number
    P030031/S025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON (B)(6) 2019, IT WAS DETERMINED THAT CONCOMITANT MED PRODUCTS WAS NOT POPULATED ADDNL. MANF. NARRATIVE/CORRECTIVE DATA DID NOT INCLUDE CONCOMITANT PRODUCTS. THEREFORE, A SUPPLEMENTAL 3500A REPORT IS BEING SUBMITTED TO PROVIDE THE CONCOMITANT PRODUCTS. CONCOMITANT PRODUCTS: 1. NON-BIOSENSE WEBSTER, INC. PRODUCT - ST. JUDE MEDICAL - BRK TRANSSEPTAL NEEDLE CATALOG #: UNKNOWN LOT #: UNKNOWN MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 72-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, AFTER AFIB WAS COMPLETED AND WERE BURNING AT CAVOTRICUSPID LINE (CTI), THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE) CATHETER. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION PURPOSES. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT¿S OUTCOME WAS IMPROVED. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITION. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. 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. 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. 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 30075917L NUMBER AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, AFTER AFIB WAS COMPLETED AND WERE BURNING AT CAVOTRICUSPID LINE (CTI), THE PATIENT BECAME HYPOTENSIVE. CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ECHO (ICE) CATHETER. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION PURPOSES. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PATIENT¿S OUTCOME WAS IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. RECOMMENDED FLOW SETTINGS FOR THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER THAT WAS USED 8-15 ML/MIN DEPENDING ON THE WATTAGE APPLIED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT FOR EVALUATION ON MARCH 20, 2019. THE INITIAL VISUAL INSPECTION REVEALED THAT THERE WAS NO PHYSICAL DAMAGE OR ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239567 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30075917L 10846835003161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R