BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8360353 · Received February 21, 2019

    Report

    Report Number
    2029046-2019-02721
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    January 28, 2019
    Report Date
    January 28, 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

    ON 1/28/2019, BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A ¿THROMBUS/CLOT¿ ON THE DOME OF THE CATHETER. UPON RECEIVING THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, INITIAL VISUAL INSPECTION IDENTIFIED A ¿RED / BROWN MATERIAL ON THE DOME¿ WHICH IS CONSIDERED AN MDR REPORTABLE MALFUNCTION. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED AND THROMBUS WAS OBSERVED ON THE CATHETER TIP. 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, 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 INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE ROOT CAUSE OF THE THROMBUS OBSERVED 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 PROCEDURE. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI 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 WAS PERFORMED FOR THE FINISHED DEVICE 30104465L NUMBER, AND NO NON-CONFORMANCES WAS FOUND DURING THE REVIEW. (B)(6). MANUFACTURER'S REF. (B)(4).

    Description of Event or Problem · 1

    ON 1/28/2019, BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A ¿THROMBUS/CLOT¿ ON THE DOME OF THE CATHETER. UPON RECEIVING THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, INITIAL VISUAL INSPECTION IDENTIFIED A ¿RED / BROWN MATERIAL ON THE DOME¿ WHICH IS CONSIDERED AN MDR REPORTABLE MALFUNCTION. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS RETURNED LABELED WITH A COMPLAINT NUMBER FOR WHICH PRODUCT DETAILS, SUCH AS THE LOT NUMBER, DO NOT MATCH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION FOR THE WRONG PRODUCT RECEIVED, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. A NEW COMPLAINT WAS CREATED TO INVESTIGATE AND REPORT THE MALFUNCTION FOUND ALTHOUGH NO SPECIFIC EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152375 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30104465L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1