BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9533888 · Received December 30, 2019

    Report

    Report Number
    2029046-2019-04080
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 4, 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

    ON 1/6/2020, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND THE DOME WAS PARTIALLY COVERED IN DARK RED-BROWN MATERIAL WHICH WAS DETERMINED TO BE A THROMBUS FORMATION ON THE ABLATION CATHETER DOME. THE FINDING IS CONSISTENT WITH THE CUSTOMER¿S REPORTED ISSUE AND CONTINUES TO BE CONSIDERED AN MDR REPORTABLE MALFUNCTION. 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. ADDITIONALLY, IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A THROMBUS ISSUE OCCURRED. DURING THE ABLATION, THROMBUS WAS FOUND AT THE TIP OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE SAME ISSUE OCCURRED WITH THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE ISSUES WERE RESOLVED BY REPLACING BOTH DEVICES AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ON 12/26/2019, BIOSENSE WEBSTER INC. (BWI) RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS REPORTED THAT THE SETTINGS ON THE SMARTABLATE GENERATOR WERE SET TO THE WRONG SETTING BY THE MEDICAL ENGINEER AS NON-IRRIGATED 4MM CATHETER. AFTER CONFIRMING THE WRONG SETTING, THE PHYSICIAN REMOVED THE CATHETER AND CONFIRMED THE THROMBUS. THE ISSUE WAS RESOLVED BY CHANGING THE DEVICES. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS INSPECTED, AND THE TOP OF THE DOME WAS PARTIALLY COVERED IN DARK RED / BROWN MATERIAL. THEN, DURING THE SECOND VISUAL IT WAS FOUND TO BE THROMBUS ON DOME. THE TEMPERATURE WAS TESTED AND NO ISSUES WERE OBSERVED. AN IRRIGATION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS IRRIGATING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT HAS BEEN CONFIRMED. THE ROOT CAUSE OF THE CLOT REPORTED BY THE CUSTOMER COULD BE RELATED TO THE USAGE OF THE DEVICE DURING THE PROCEDURE, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF #: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A THROMBUS ISSUE OCCURRED. DURING THE ABLATION, THROMBUS WAS FOUND AT THE TIP OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE SAME ISSUE OCCURRED WITH THE PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE ISSUES WERE RESOLVED BY REPLACING BOTH DEVICES AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ON 12/26/2019, BIOSENSE WEBSTER INC. (BWI) RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS REPORTED THAT THE SETTINGS ON THE SMARTABLATE GENERATOR WERE SET TO THE WRONG SETTING BY THE MEDICAL ENGINEER AS NON-IRRIGATED 4MM CATHETER. AFTER CONFIRMING THE WRONG SETTING, THE PHYSICIAN REMOVED THE CATHETER AND CONFIRMED THE THROMBUS. THE ISSUE WAS RESOLVED BY CHANGING THE DEVICES. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE ISSUE OF THROMBUS FORMATION ON THE DEVICES HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323548 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D134805 30283784M 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 PREF.GUIDING SHEATH W/MULT.CRV.| SMARTABLATE GENERATOR KIT-WW.