BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9282423 · Received November 5, 2019

    Report

    Report Number
    2029046-2019-03855
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 11, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2019. UPON INITIAL VISUAL INSPECTION, IT WAS REPORTED THAT THERE WAS DARK RED / BLACK MATERIAL ON THE DOME OF THE CATHETER. 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. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A THROMBUS ISSUE OCCURRED. INVESTIGATION ANALYSIS WAS COMPLETED ON (B)(6) 2019. THE DEVICE WAS VISUALLY INSPECTED AND DARK RED MATERIAL WAS FOUND ON THE DOME. DURING THE SECOND VISUAL INSPECTION, THROMBUS WAS IDENTIFIED AS THE MATERIAL ON THE DOME. 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. A COOL FLOW PUMP TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING CORRECTLY, NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMITIES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE THROMBUS FOUND ON THE DOME CANNOT BE DETERMINED HOWEVER, THIS COULD BE RELATED TO THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER (B)(6)2019. SMART ABLATE GENERATOR WAS USED DURING THE PROCEDURE. THERE WERE NO ERROR MESSAGES AND THE PHYSICIAN/USER DID NOT SEE ANY PRODUCT PROBLEM. D11 HAS BEEN UPDATED TO INCLUDE THE SMARTABLATE GENERATOR. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30255929M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A THROMBUS ISSUE OCCURRED. DURING THE PROCEDURE, THROMBUS WAS DISCOVERED ON THE TIP OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE THROMBUS ON THE TIP OF THE CATHETER WAS ASSESSED AS A REPORTABLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074697 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30255929M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK_SMARTABLATE GENERATOR.