BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 14599630 · Received June 5, 2022

    Report

    Report Number
    2029046-2022-01194
    Event Type
    Malfunction
    Date Received
    June 5, 2022
    Date of Event
    February 9, 2022
    Report Date
    June 5, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009002
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION 22-MAR-2022. THE INVESTIGATION WAS COMPLETED ON 11-MAY-2022. AN ANALYSIS WAS PERFORMED ON THE PICTURES THAT WERE PROVIDED BY THE CUSTOMER. ACCORDING TO PICTURES PROVIDED BY CUSTOMER, REDDISH MATERIAL WAS OBSERVED INSIDE OF THE PEBAX. HOWEVER, NO EXTERNAL DAMAGE WAS OBSERVED. CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURES RECEIVED. THE PRODUCT ANALYSIS WAS PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION AND SCREENING TEST OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS REVEALED A HOLE ON THE PEBAX WITH REDDISH MATERIAL INSIDE. A SCREENING TEST WAS PERFORMED, AND THE DEVICE WAS NOT VISUALIZED, ERROR 105 APPEARED DUE TO AN OPEN CIRCUIT ON THE TIP AREA. THE EVALUATION DETERMINED THAT THE CAUSE OF PEBAX DAMAGE FAILURE CANNOT BE ESTABLISHED. THE EVENT DESCRIBED WAS UNABLE TO BE DUPLICATED DURING THE PRODUCT INVESTIGATION. HOWEVER, THE BLOOD FOUND INSIDE THE PEBAX AREA MAY BE CONTRIBUTED TO THE FORCE HIGH REPORTED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED CATHETER BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB OBSERVED A HOLE ON THE PEBAX. INITIALLY, AFTER ZEROING, THE CATHETER STARTED SHOWING CONSTANTLY THE 'CATHETER TOUCHING' ICON AND THE FORCE WAS SHOWING SIGNIFICANT FORCE SPIKES AND/OR N/A FORCE INDICATION. A NEW CABLE WAS OPENED BUT THE ISSUE PERSISTED. THEREFORE, THE CATHETER WAS INSPECTED AND THE FORCE SENSOR SEEMED TO BE SURROUNDED BY LIQUID (BLOOD). A NEW CATHETER WAS OPENED TO CONTINUE WITH THE PROCEDURE. THE PATIENT WAS SAFE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE SHEATH USED WAS THE ABBOTT AGILIS NTX STEERABLE SHEATH 8.5F. THERE WAS NO DIFFICULTY EXPERIENCED AT ANY POINT MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THERE WAS NO PHYSICAL DAMAGE OF THE PEBAX NOTED DURING A QUICK INSPECTION. 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 FORCE SENSOR ISSUE WAS ASSESSED AS NOT MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PEBAX WITH NO EXTERNAL DAMAGE. SINCE THERE WAS NO DAMAGE TO THE PEBAX INTEGRITY, THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 11-MAY-2022 THERE WAS A HOLE WITH REDDISH-BROWN MATERIAL OBSERVED ON THE PEBAX. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 11-MAY-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323671 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D133602 30498484M 10846835009002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NON BWI-ABBOTT AGILIS NTX STEERABLE SHEATH 8.5F| UNKNOWN BRAND CABLE| UNKNOWN BRAND CABLE| UNKNOWN BRAND CATHETER