BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16549637 · Received March 15, 2023

    Report

    Report Number
    2029046-2023-00538
    Event Type
    Death
    Date Received
    March 15, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME (CONT.): (B)(6) MEDICAL CENTER. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, 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 803. 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 A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED HYPOTENSION REQUIRING SURGICAL INTERVENTION AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT AFTER A PREMATURE VENTRICULAR CONTRACTION (PVC) CASE, THE PATIENT SUFFERED AN ADVERSE EVENT THAT RESULTED IN DEATH. THE BIOSENSE WEBSTER INC (BWI) REPRESENTATIVE REPORTED THERE WERE NO VISIBLE SIGNS OF AN ISSUE WITH THE PATIENT DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, ST ELEVATION WAS NOTED ON THE EKG AND THE PATIENT BECAME HYPOTENSIVE. THE PATIENT WAS STABILIZED AND THEN TAKEN UP FOR A HEART CATHETERIZATION. THEY BELIEVED THE PATIENT MUST HAVE CRASHED SHORTLY AFTER. THE BWI REPRESENTATIVE HAS NOT SPOKEN TO THE PHYSICIAN SINCE THE PATIENT¿S DEATH. THE ADVERSE EVENT AND DATE OF DEATH OCCURRED ON (B)(6) 2023. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THE PATIENT WAS TAKEN TO THE CATH LAB FOR CORONARY ASSESSMENT, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND CARDIOPULMONARY RESUSCITATION (CPR). GENERATOR INFORMATION WAS A SMARTABLATE, SN # (B)(4). IN PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS UNKNOWN. NO AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143197 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death SMARTABLATE GENERATOR KIT-US