BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11510343 · Received March 18, 2021

    Report

    Report Number
    2029046-2021-00377
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    August 3, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI CONDUCTED A VISUAL INSPECTION AND A GENERATOR COMPATIBILITY EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SMART TOUCH CATHETER. THE CATHETER WAS CONNECTED TO GENERATOR AND THE TEMPERATURE OF THE CATHETER WAS MEASURED. NO TEMPERATURE ISSUES WERE OBSERVED. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED SINCE THE CATHETER PERFORMED WITHOUT ANY TEMPERATURE ISSUES. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. AS SUCH, BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MFR # 2029046-2020-01133 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER). MFR # 2029046-2021-00377 FOR PRODUCT CODE D132705 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH TWO (2) THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WHEREIN A PROCEDURE CANCELLATION OCCURRED INCREASING RISK TO PATIENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WHERE HANDLE WAS OVERHEATING. THE CATHETER WAS REPLACED WITH A 2ND THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER FROM THE SAME LOT # AND THE ISSUE REOCCURRED. THE PROCEDURE HAD TO BE CANCELLED. PATIENT WAS UNDER GENERAL ANESTHESIA AND TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. IN THE PHYSICIAN¿S OPINION, CANCELLATION OF THE PROCEDURE DID NOT CONTRIBUTE TO A SERIOUS INJURY OF THE PATIENT. THE CUSTOMER¿S ISSUE OF THE HANDLE OVERHEATING IS NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409336 THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 30329824M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 THMCL SMRTTCH,BI,NAV,TC,D-F,C3