BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16155605 · Received January 13, 2023

    Report

    Report Number
    2029046-2023-00092
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    November 1, 2022
    Report Date
    January 12, 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 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 08-DEC-2022. THE DEVICE EVALUATION WAS COMPLETED ON 16-DEC-2022. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED; HOWEVER, IT COULD BE RELATED TO THE HANDLING DURING THE RETURN TO BE ANALYZED BUT, IT CANNOT BE CONCLUSIVELY DETERMINED. A DEFLECTION TEST WAS PERFORMED AND THE CURVE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION ISSUES WERE OBSERVED. THE DEFLECTION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: DO NOT MANUALLY PRE-SHAPE THE DISTAL SHAFT OF THE CATHETER BY APPLYING EXTERNAL FORCES INTENDED TO BEND OR AFFECT THE INTENDED SHAPE OR CURVE OF THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. 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® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER¿S INC. PRODUCT ANALYSIS LAB OBSERVED THE PEEK HOUSING BROKEN LEAVING INTERNAL PARTS EXPOSED. INITIALLY IT WAS REPORTED THAT THERE WAS A DEFLECTION ISSUE. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. 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) 2022, THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED; HOWEVER, IT COULD BE RELATED TO THE HANDLING DURING THE RETURN TO BE ANALYZED BUT, IT CANNOT BE CONCLUSIVELY DETERMINED. THE PEEK HOUSING BROKEN LEAVING INTERNAL PARTS EXPOSED WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187029 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30758555L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND CATHETER