BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10121653 · Received June 4, 2020

    Report

    Report Number
    2029046-2020-00658
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER (AFL) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE IN THE PEBAX.INITIALLY, IT WAS REPORTED THAT THE CARTO HAD A MAGNETIC SENSOR ERROR. THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6) 2020. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. A SECOND CLOSER INSPECTION WAS PERFORMED AND REDDISH MATERIAL AND A HOLE ON WAS FOUND ON THE PEBAX. THEN, MAGNETIC SENSOR FUNCTIONALITY WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED WITH NO ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE REDDISH MATERIAL AND HOLE ON PEBAX 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 HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. WE ARE WORKING ON THE MANUFACTURING RECORD EVALUATION (MRE). ONCE THE INFORMATION IS PROVIDED, IT WILL BE SUBMITTED IN THE SUPPLEMENTAL. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REF NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER (AFL) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND A HOLE IN THE PEBAX. INITIALLY, IT WAS REPORTED THAT THE CARTO HAD A MAGNETIC SENSOR ERROR. ERROR CODE UNKNOWN. THE MAPPING CABLE WAS REPLACED AND THE ISSUE DID NOT RESOLVE. THE MAPPING CATHETER WAS REPLACED AND THE ISSUE RESOLVED. CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED MAGNETIC SENSOR ERROR 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. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION AND FOUND A HOLE IN THE PEBAX. THE OBSERVED HOLE IN THE PEBAX HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THE AWARENESS DATE HAS BEEN RESET TO 5/6/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581372 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30307178MA 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1