BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 10576684 · Received September 23, 2020

    Report

    Report Number
    2029046-2020-01313
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    July 7, 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

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE CATHETER WAS INSPECTED AND THE FOLLOWING WAS IDENTIFIED: DAMAGED DOME, DAMAGED ELECTRODES, A HOLE IN THE PEBAX, EXPOSED INTERNAL PARTS, AND CRACKED PEEK HOUSING. THEN, MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER FAILED, ERROR 106 WAS OBSERVED. A FAILURE ANALYSIS WAS PERFORMED, AND THE CATHETER WAS DISSECTED ON THE TIP AREA, LOSS OF ELECTRICAL CONTINUITY AT THE SENSOR WAS FOUND, IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE ELECTRODES DAMAGED, HOLE ON PEBAX, INTERNAL PARTS EXPOSED, PEEK HOUSING CRACKED AND FORCE SENSOR CABLE 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED THE FOLLOWING: DAMAGED DOME, DAMAGED ELECTRODES, HOLE IN THE PEBAX, EXPOSED INTERNAL PARTS, AND DAMAGED PEEK HOUSING. DURING THE PROCEDURE, THE PHYSICIAN NOTICED AN UNSTABLE PRESSURE VALUE. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PATIENT. THE FORCE/PRESSURE VALUE ISSUE NOTED DURING THE PROCEDURE IS NOT REPORTABLE. HOWEVER, THE CATHETER DAMAGE IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042075 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC 30303496M

    Patients

    Seq Age Sex Outcome Treatment
    1