BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 10583729 · Received September 24, 2020

    Report

    Report Number
    2029046-2020-01322
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS VISUALLY INSPECTED, AND THE PEBAX WAS FOUND DAMAGED (HOLE) WITH FOREIGN MATERIAL INSIDE. THEN, MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR FEATURE WAS TESTED, AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT REGARDING FORCE ISSUE COULD NOT BE DUPLICATED DURING THE PRODUCT INVESTIGATION. HOWEVER, IT WAS DETERMINED THAT THE FOREIGN MATERIAL INSIDE THE PEBAX AREA COULD BE RELATED TO THE REPORTED ISSUE. THE ROOT CAUSE OF THE PEBAX DAMAGE CANNOT BE RELATED TO THE MANUFACTURING PROCESS AS THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE DAMAGE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX WITH FOREIGN MATERIAL INSIDE. DURING THE PROCEDURE, NO FORCE VALUES WERE BEING DISPLAYED. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO REPORT OF AN ADVERSE EVENT FOR THE PATIENT. THE FORCE ISSUE DURING THE PROCEDURE IS NOT MDR REPORTABLE. HOWEVER, THE HOLE IN THE PEBAX WITH FOREIGN MATERIAL INSIDE IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046139 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC 30307857M

    Patients

    Seq Age Sex Outcome Treatment
    1