BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9339045 · Received November 18, 2019

    Report

    Report Number
    2029046-2019-03890
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER, AND A THROMBUS ISSUE OCCURRED. DURING THE PROCEDURE, A STEAM POP OCCURRED AT THE ROOF OF THE LEFT SUPERIOR PULMONARY VEIN. ON 12/25/2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING A STEAM POP OCCURRED WHILE ABLATING IN THE ROOF OF LEFT SUPERIOR PULMONARY VEIN. THERE WERE NO ERROR MESSAGES. WHEN THE STSF CATHETER WAS REMOVED, THROMBUS HAD ATTACHED TO THE TIP. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE COMPLAINT PRODUCT(S) WILL BE RETURNED FOR ANALYSIS. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 11/5/2019, THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION. UPON RECEIPT, REDDISH-BROWN MATERIAL WAS FOUND ON THE DOME. ON 11/7/2019 A SECOND VISUAL INSPECTION CONFIRMED THE INITIAL FINDINGS OF REDDISH-BROWN MATERIAL ON THE DOME. THESE FINDINGS COINCIDE WITH WHAT WAS REPORTED. FURTHER TESTING WAS THEN PERFORMED. THE INVESTIGATIONAL ANALYSIS COMPLETED 11/12/2019. THE RETURNED DEVICE WAS INSPECTED AND REDDISH BROWN MATERIAL WAS OBSERVED ON THE CATHETER DOME. DURING THE SECOND VISUAL IT WAS CLARIFIED THAT THE MATERIAL OBSERVED ON THE TIP WAS THE THROMBUS, REPORTED BY THE CUSTOMER. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND STOCKERT COMPATIBILITY. IT WAS FOUND TO BE WITHIN SPECIFICATIONS. COOL FLOW PUMP TESTING WAS THEN PERFORMED AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. A PATENCY TEST WAS PERFORMED. IT WAS DETERMINED THAT NOT ALL THE HOLES WERE IRRIGATING. THIS IS RELATED TO THE THROMBUS OBSERVED, SINCE THIS MATERIAL WAS OBSTRUCTING THE DOME HOLES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE THROMBUS REPORTED CANNOT BE RELATED TO THE MANUFACTURING PROCESS, SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT COULD BE RELATED TO THE USE OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER, AND A THROMBUS ISSUE OCCURRED. DURING THE PROCEDURE, A STEAM POP OCCURRED AT THE ROOF OF THE LEFT SUPERIOR PULMONARY VEIN. THE STSF CATHETER WAS REMOVED AND THROMBUS WAS OBSERVED ATTACHED TO THE TIP. CATHETER REPLACEMENT RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED STEAM POP HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE THROMBUS ISSUE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128640 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30252053M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1