BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 9657169 · Received February 2, 2020

    Report

    Report Number
    2029046-2020-00173
    Event Type
    Malfunction
    Date Received
    February 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009293
    PMA / PMN Number
    P030031/S034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A RADIO FREQUENCY CATHETER ABLATION (RFCA) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND ELECTRODE DAMAGE AND THE PEEK HOUSING CRACKED WITH EXPOSED PARTS. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WOULD NOT DEFLECT. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS INSPECTED, AND THE DOME WAS OBSERVED TO BE DENTED AND ONE RING LIFTED WITH NO POLYURETHANE (PU) ON EDGE, THE PEEK HOUSING WAS BROKEN, AND SOME CONNECTOR PINS BENT. A DEFLECTION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [17736186L] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE WAS DEFLECTING CORRECTLY. THE ROOT CAUSE OF THE DAMAGE OBSERVED ALONG THE CATHETER, CANNOT BE RELATED TO THE MANUFACTURE PROCESS. IT COULD BE RELATED TO THE HANDLING DURING SHIPMENT AFTER PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURER'S REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RADIOFREQUENCY CATHETER ABLATION (RFCA) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB FOUND ELECTRODE DAMAGE AND THE PEEK HOUSING CRACKED WITH EXPOSED PARTS. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WOULD NOT DEFLECT. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. ON JANUARY 9, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND UPON INITIAL VISUAL INSPECTION IT WAS NOTED THAT THE TIP DOME WAS FLATTENED ON ONE SIDE WITH ROUND AREA PUSHED IN, THE PEEK HOUSING WAS CRACKED OPEN WITH INTERNAL WIRING EXPOSED WITH RING 2 BEING SQUASHED/DENTED, AND SOME PINS WERE FOUND BENT IN THE CONNECTOR. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH SECOND VISUAL ANALYSIS ON JANUARY 9, 2020 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS JANUARY 9, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120243 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D131503 17736186L 10846835009293

    Patients

    Seq Age Sex Outcome Treatment
    1