BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12898940 · Received November 30, 2021

    Report

    Report Number
    2029046-2021-02086
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 4, 2021
    Report Date
    February 6, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1-DEC-2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 REF. # (B)(4) ON 2-DEC-2021, IT WAS NOTICED THAT THE H6. MEDICAL DEVICE PROBLEM CODE OF "HIGH READINGS (A090807)" TO REPRESENT THE CUSTOMER'S REPORTED HIGH IMPEDANCE ISSUE WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MDR. THE CODE HAS NOW BEEN ADDED.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT NO ERROR WAS NOTED FROM THE IRRIGATION PUMP AND THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES NOR DID THE PHYSICIAN/USER SEE ANY PRODUCT PROBLEM. THE THROMBUS CONFIRMED TO BE ON THE TIP OF THE ELECTRODE. AS SUCH, THIS FINDING IS CONSIDERED TO BE AN ISSUE OF ¿CHAR¿ ON THE CATHETER TIP AND NOT CONSIDERED TO BE MDR REPORTABLE. CHAR IS A PHYSICAL PHENOMENON OF RF ENERGY DELIVERY AND CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR ON THE ELECTRODES DOES NOT REPRESENT A SERIOUS INJURY IN ITSELF, NOR IS IT NECESSARILY THE RESULT OF DEVICE MALFUNCTION. IN ADDITION, BIOSENSE WEBSTER INC. HAS REASSESSED THE REPORTABILITY OF CHAR-RELATED EVENTS AND HAS DETERMINED THAT THESE EVENTS, WHICH WERE PREVIOUSLY REPORTED AS MALFUNCTIONS, ARE ¿NOT REPORTABLE.¿ THE FDA HAS PROVIDED DOCUMENTED CONCURRENCE WITH THIS ASSESSMENT. THIS EVENT WILL NO LONGER BE CONSIDERED TO BE MDR REPORTABLE. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE CATHETER HAD A THROMBUS ATTACHED WHEN IT WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT AFTER FINISHING ISOLATION OF LEFT PULMONARY VEIN (LPV), WHEN ABLATION WAS CONDUCTED FOR RIGHT PULMONARY VEIN (RPV), IMPEDANCE ROSE ABOUT 15 OHM. THE STSF WAS REMOVED FROM THE PATIENT¿S BODY AND FLUSH WAS CONDUCTED, AND IT WAS CONFIRMED THAT THE DEVICE WAS NOT IRRIGATING FROM THE VICINITY OF THE TIP. THE CATHETER WAS CHANGED AND THE ISSUE RESOLVED. HOWEVER, AFTER ISOLATION WAS FINISHED, ABLATION WAS CONDUCTED FOR ROOF AND AFTER THAT, DURING BOTTOM ABLATION, IMPEDANCE ROSE ABOUT 15 OHM. WHEN THE CATHETER WAS REMOVED AGAIN, THERE WAS A THROMBUS ATTACHED. WHICH WAS RESOLVED BY CHANGING THE CATHETER AGAIN. ALTHOUGH THERE WAS NO THROMBUS ATTACHED, WHICH CAN BE CONFIRMED BY THE FIRST CATHETER, THE THROMBUS FORMATION IS SUSPECTED BECAUSE THE THROMBUS DID NOT FLOW FROM THE TIP DURING THE CASE EVEN THOUGH IT WAS UNIFORMLY FLOWING BEFORE INTRACARDIAC INSERTION. THE SECOND CATHETER (THE COMPLAINT DEVICE) WAS CONFIRMED TO HAVE A THROMBUS ATTACHED. THERE SEEMED TO BE NO PARTICULAR EFFECT ON PATIENT--NO PATIENT CONSEQUENCES WERE REPORTED. THROMBUS/CLOT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795671 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134804 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THERMOCOOL SMARTTOUCH