BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8611830 · Received May 15, 2019

    Report

    Report Number
    2029046-2019-03146
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/25/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS OBSERVED NO VISUAL DAMAGE OR ANOMALIES. 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. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PATIENT WAS STABLE AFTER PERICARDIAL DRAINAGE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE EVENT TO A BWI PRODUCT MALFUNCTION. 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. THEN, 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. 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 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 30160077L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN, AND 280 CC OF FLUID WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABLE AFTER PERICARDIAL DRAINAGE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT¿S OUTCOME. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE EVENT TO A BWI PRODUCT MALFUNCTION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK-1 TRANSSEPTAL NEEDLE. THERE WAS NO PERICARDIAL EFFUSION PRESENT PRIOR TO THE ABLATION. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE FLOW WAS SET WITHIN NORMAL SETTINGS FOR THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER BASED ON THE WATTAGE APPLIED. NO ERRORS WERE OBSERVED ON THE CARTO 3 SYSTEM DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405666 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30160077L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R