BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 11622985 · Received April 6, 2021

    Report

    Report Number
    2029046-2021-00521
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/19/2021, THE COMPLAINT DEVICE WAS PHYSICALLY INSPECTED AND MDR-REPORTABLE DAMAGE WAS NOTED: THERE WAS A HOLE ON THE PEBAX'S SURFACE. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI THEN CONDUCTED VISUAL INSPECTION AND FORCE SENSOR FUNCTIONALITY EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE. FORCE TEST WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE RETURNED SAMPLE WAS CONNECTED TO CARTO 3 SYSTEM AND ERROR 106 WAS DISPLAYED ON THE SCREEN. FOR THIS REASON, THE CATHETER WAS DISSECTED ON THE TIP AREA, LOSS OF ELECTRICAL CONTINUITY OF THE GREEN PAIRED WIRES TO SENSOR WAS FOUND. CONCLUDING THAT IS AN INTERNAL FAILURE OF THE SENSOR. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30482199M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: TO ENSURE ACCURATE FORCE READINGS, VERIFY THAT THE FORCE READING IS NEAR ZERO WHEN THE CATHETER IS NOT IN CONTACT WITH TISSUE. IF THE FORCE READING IS NOT NEAR ZERO WHEN THE CATHETER IS NOT IN CONTACT WITH TISSUE, PERFORM ZEROING. IF THE FORCE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. ON OTHER HAND, REGARDING THE ADDITIONAL FINDING OBSERVED, THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING INFORMATION: IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. FOREIGN MATERIAL FOUND INSIDE THE PEBAX. IT WAS REPORTED THAT ERROR CODE 84,86,87,88 DISPLAYED DURING THE LA MAPPING. PHYSICIAN SWITCHED THE CONNECTOR CABLES, BUT THE PROBLEM COULDN'T BE RESOLVED. THEN PHYSICIAN REMOVED THE CATHETER FOR CHECKING AND FOUND FOREIGN MATERIAL SUCH AS BLOOD INSIDE THE PEBAX. THE INTEGRITY OF THE PEBAX SLEEVE HAS NOT BEEN COMPROMISED (NO OPENINGS ARE PRESENT THAT WOULD ALLOW FLUID OR COMPONENTS ENTER OR EXIT THE SLEEVE AREA). PHYSICIAN SWITCHED ANOTHER NEW CATHETER TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED. FOREIGN MATERIAL INSIDE OF THE PEBAX IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519805 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC 30482199M

    Patients

    Seq Age Sex Outcome Treatment
    1