BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12426063 · Received September 3, 2021

    Report

    Report Number
    2029046-2021-01486
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 19-JUL-2021. THE DEVICE EVALUATION WAS COMPLETED ON 12-AUG-2021. THE CATHETER WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BIOSENSE WEBSTER, INC. CONDUCTED A VISUAL INSPECTION AND SHAFT PROXIMITY INTERFERENCE (SPI) SCREENING TEST OF THE RETURNED CATHETER. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE AND A HOLE ON THE PEBAX ON THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. SPI SCREENING TEST WAS PERFORMED, IN ACCORDANCE WITH BIOSENSE WEBSTER, INC. PROCEDURES. THE RETURNED SAMPLE WAS CONNECTED TO CARTO 3 SYSTEM AND THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THE EVALUATION DETERMINED THAT THE CAUSE OF PEBAX DAMAGE FAILURE CANNOT BE ESTABLISHED. THE EVENT DESCRIBED FORCE ISSUE WAS UNABLE TO DUPLICATE DURING THE PRODUCT INVESTIGATION; HOWEVER, THE BLOOD INSIDE THE PEBAX AREA FOUND COULD BE RELATED TO THE REPORTED ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER, INC.¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. TO MINIMIZE FORCE ISSUES, THE FOLLOWING GUIDELINES SHOULD BE FOLLOWED. IN ORDER TO ACHIEVE OPTIMAL FORCE READING ACCURACY AND STABILITY, ALLOW THE CATHETER TO WARM UP FOR 2 MINUTES AFTER CONNECTION TO THE CARTO¿3 SYSTEM, PRIOR TO USE OF THE FORCE FEEDBACK FEATURE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED A HOLE ON THE PEBAX. INITIALLY, DURING THE ABLATION, THE FORCE CONSISTENTLY DISPLAYED "HIGH" EVEN WHEN THE CATHETER WAS NOT IN CONTACT. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS DISCOVERED THAT THE BLOOD HAD INFILTRATED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE HIGH FORCE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE 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 PER THE EVALUATION COMPLETION ON 12-AUG-2021 THERE WAS REDDISH MATERIAL AND A HOLE ON THE PEBAX OBSERVED. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 12-AUG-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321185 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30494771L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1