BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9785941 · Received March 4, 2020

    Report

    Report Number
    2029046-2020-00345
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    December 4, 2019
    Report Date
    December 4, 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 · 1

    (B)(6). THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. INVESTIGATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED AND NO PHYSICAL DAMAGE OBSERVED. DURING A SECOND CLOSER INSPECTION, A HOLE ON THE PEBAX WITH REDDISH MATERIAL AND INTERNALS PARTS EXPOSED WERE FOUND. THE MAGNETIC AND FORCE FEATURES WERE TESTED AND NO ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE PEBAX 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. MANUFACTURER'S REFERENCE NUMBER: (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 THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB NOTED A HOLE ON THE PEBAX. INITIALLY, IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING ABLATION, THE CONTACT FORCE BECAME HI. THE CABLE WAS CHANGED BUT THE ISSUE CONTINUED. THE ISSUE WAS RESOLVED BY CHANGING THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE HIGH FORCE WAS ASSESSED AS NOT REPORTABLE. THIS ISSUE WAS HIGHLY DETECTABLE WHEN OCCURRING. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS LOW. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND NOTED ON FEBRUARY 19, 2020 A HOLE ON THE PEBAX AND REDDISH-BROWN MATERIAL INSIDE THE PEBAX. THE HOLE ON THE PEBAX WAS ASSESSED AS A REPORTABLE ISSUE. THE AWARENESS DATE OF THIS LAB FINDING IS FEBRUARY 19, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250821 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30273497M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1