BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 17547046 · Received August 14, 2023

    Report

    Report Number
    2029046-2023-01777
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    June 1, 2023
    Report Date
    August 14, 2023
    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

    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. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION (B)(6) 2023. THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2023. THE SMART TOUCH UNIDIRECTIONAL DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. THE COMPLAINT CATHETER WAS INSPECTED, REDDISH MATERIAL WAS OBSERVED IN THE PEBAX AND IT WAS FOUND SEPARATED FROM ELECTRODE #3. DEFLECTION TESTING WAS PERFORMED, AND THE DEFLECTION MECHANISM FAILED SPECIFICATIONS DUE TO THE PULLER WIRE WAS FOUND BROKEN INSIDE THE HANDLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07)/INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)/COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿FOREIGN MATERIAL INSIDE THE PEBAX WITH EXTERNAL DAMAGE¿ ISSUE. -INVESTIGATION FINDINGS: FRACTURE PROBLEM (C070603)/INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15)/COMPONENT CODE: STEERING WIRE (G04121) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿DEFLECTION¿ ISSUE. 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 FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED FOREIGN MATERIAL INSIDE THE PEBAX WITH EXTERNAL DAMAGE. INITIALLY A DEFLECTION ISSUE WAS REPORTED. DURING THE PROCEDURE, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. 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. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2023 THERE WAS REDDISH MATERIAL OBSERVED IN THE PEBAX AND IT WAS FOUND SEPARATED FROM ELECTRODE #3. THE RETURNED CONDITION WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PEBAX WITH EXTERNAL DAMAGE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995178 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30992703M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown