BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8525561 · Received April 17, 2019

    Report

    Report Number
    2029046-2019-03003
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    December 4, 2018
    Report Date
    December 4, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE OVER THE PEBAX. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS 31 TECHNOLOGY DR. IRVINE, CA 92618. THE CORRECT ADDRESS IS 33 TECHNOLOGY DR. IRVINE , CA 92618. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONAL ANALYSIS COMPLETED ON 4/5/2019. THE DEVICE WAS VISUALLY INSPECTED AND REDDISH MATERIAL WAS FOUND INSIDE THE PEBAX WITH NO INTERNAL PARTS EXPOSED. DURING THE SECOND VISUAL INSPECTION REDDISH MATERIAL AND HOLE IN THE PEBAX WAS OBSERVED. THE MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED WITH NO ERRORS WERE OBSERVED. THE FORCE SENSOR FEATURE WAS TESTED AND IT WAS WORKING PROPERLY. THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. ON 4/2/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS RELATED TO THIS COMPLAINT WERE FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON 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. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE OVER THE PEBAX. INITIALLY IT WAS REPORTED THAT 100 GRAMS OF FORCE WAS DISPLAYED AND THE VECTOR WOULD FLIP BACK WARDS WHEN COMING ON ABLATION. THE CABLE WAS REPLACED AND THE ISSUE REMAINED. CATHETER REPLACEMENT RESOLVED THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE HIGH FORCE AND INVERTED VECTOR ISSUES HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE DURING A SECOND VISUAL INSPECTION ON 3/21/2019, THE BWI PAL FOUND REDDISH MATERIAL IN THE PEBAX WITH NO INTERNAL PARTS EXPOSED AND A HOLE OVER THE PEBAX. THE REDDISH MATERIAL HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE OBSERVED HOLE OVER THE PEBAX HAS BEEN ASSESSED AS MDR REPORTABLE AS THE DEVICE INTEGRITY WAS COMPROMISED. THE AWARENESS DATE HAS BEEN RESET TO 3/21/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317277 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30090743L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1