BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15334674 · Received September 1, 2022

    Report

    Report Number
    2029046-2022-02077
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    March 23, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SHAFT WAS BENT CLOSE TO THE TRANSITION AREA, ALSO RINGS LIFTED. HOWEVER, RESIDUES OF POLYURETHANE (PU) WERE OBSERVED THAT INDICATE PROPER MANUFACTURING IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER IS RECOMMENDED FOR USE WITH A LESS THAN 8.5 FRENCH IN ORDER TO AVOID DAMAGE TO THE CATHETER SHAFT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER PMA # P030031/S053 IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF.# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ELECTRODE DAMAGE. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT BEFORE THE OPERATION, THE SHAFT ON THE CATHETER WAS BENT (NO EXPOSED WIRES). A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT AS THE DEVICE WAS NOT USED IN PATIENT. THE CUSTOMER¿S REPORTED ISSUE OF BENT IN THE SHAFT IS NOT MDR REPORTABLE SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 5-AUG-2022, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SHAFT WAS BENT CLOSE TO THE TRANSITION AREA AND ALSO IDENTIFIED RINGS TO BE LIFTED. THIS FINDING WAS REVIEWED AND DETERMINED TO BE AN MDR REPORTABLE MALFUNCTION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH VISUAL ANALYSIS ON 5-AUG-2022 AND REASSESSED IT AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806367 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30679549M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THMCL SMARTTOUCH,TC,D,C3,OBL