BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9455893 · Received December 12, 2019

    Report

    Report Number
    2029046-2019-03987
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 18, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6)2020. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. ELECTRICAL TESTING WAS PERFORMED ON THE CATHETER AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. DEFLECTION TESTS WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATION. THE CATHETER WAS DEFLECTING CORRECTLY. THE MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER FAILED. ERROR 106 WAS OBSERVED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS DISSECTED ON THE TIP AREA. LOSS OF ELECTRICAL CONTINUITY AT THE SENSOR WAS FOUND. IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. IRRIGATION TESTS WERE PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS DISSECTED AND REDDISH BROWN MATERIAL WAS FOUND OCCLUDING THE DOME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE INTERNAL FAILURE OF THE SENSOR CANNOT BE DETERMINED. 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 OCCLUSION IN DOME CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT A FEMALE PATIENT UNDERWENT AN ATYPICAL ATRIAL FLUTTER ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED COMPLETE HEART BLOCK REQUIRING A PERMANENT PACEMAKER IMPLANTED. THE PATIENT REMAINED STABLE AND WILL BE TRANSFERRED TO THE CLINICAL CARE UNIT FOR OBSERVATION. THE PHYSICIAN STATED THAT THE PROCEDURE WAS THE CAUSE. THE AREA OF INTEREST WAS BELOW THE BUNDLE OF HIS, ANTERIOR TO THE CORONARY SINUS. THE LAST ABLATION RESULTED IN A HEART BLOCK. A BI-V PACEMAKER WAS IMPLANTED, AND THE PATIENT¿S CONDITION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257463 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30273577M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S