BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15353486 · Received September 3, 2022

    Report

    Report Number
    2029046-2022-02102
    Event Type
    Injury
    Date Received
    September 3, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 64-YEAR-OLD PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT-LEFT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED HEART BLOCK REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, A HEART BLOCK WAS DISCOVERED WITHIN A COUPLE OF SECONDS OF COMING ON ABLATION. THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE HEART BLOCK WAS CONFIRMED ON THE ECG SIGNALS FROM THE BODY SURFACE LEADS THAT SHOWED THAT THE ATRIUM AND VENTRICLE WERE NOT COMMUNICATING. THE MEDICAL INTERVENTION PROVIDED WAS A PACEMAKER THAT WAS BEING PUT INSIDE THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS ABORTED. IT WAS BELIEVED THAT THE HEART BLOCK OCCURRED DUE TO THE LOCATION OF ABLATION BEING TOUGH TO GET TO. THE HEART BLOCK OCCURRED DUE TO DAMAGE TO THE AV NODE. ADDITIONAL INFORMATION WAS RECEIVED. PHYSICIAN CAUSED HEART BLOCK DUE TO ANATOMICAL STRUCTURES. NOT CATHETER RELATED. THE OUTCOME WAS THAT THE PATIENT RECEIVED A BI- VENTRICULAR PACEMAKER AND IS STABLE. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446997 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134702 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US