BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8468077 · Received March 31, 2019

    Report

    Report Number
    2029046-2019-02914
    Event Type
    Malfunction
    Date Received
    March 31, 2019
    Date of Event
    December 5, 2018
    Report Date
    December 20, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS INSPECTED AND IT WAS FOUND IN NORMAL CONDITION. DURING THE SECOND VISUAL INSPECTION, THE PEEK HOUSING WAS FOUND CRACKED WITH EXPOSED METALS. THEN, THE DEFLECTION TEST WAS PERFORMED AND THE CATHETER FAILED. A FAILURE ANALYSIS WAS PERFORMED AND THE CATHETER WAS OBSERVED UNDER THE X RAY MACHINE AND THE T BAR WAS FOUND SLID DOWN CAUSING THE IMPROPER DEFLECTION CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE T BAR SLIPPAGE CANNOT BE DETERMINED, HOWEVER, AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO PREVENT THIS ISSUE. THE DAMAGE OBSERVED ON THE PEEK HOUSING IS RELATED TO THE T BAR SLIPPAGE DUE TO THE STRESS APPLIED IN THE TIP AREA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB NOTED THE PEEK HOUSING CRACKED WITH METAL EXPOSED. INITIALLY, DURING THE PROCEDURE, THE CATHETER COULD NOT DEFLECT. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. SINCE THE CATHETER WAS UNABLE TO DEFLECT, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR ASSESSMENT AND ON MARCH 13, 2019 IT WAS NOTED THAT THE PEEK HOUSING WAS CRACKED WITH METAL EXPOSED. THIS LAB FINDING WAS ASSESSED AS REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS MARCH 13, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261256 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30079566M

    Patients

    Seq Age Sex Outcome Treatment
    1