BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 16284016 · Received February 2, 2023

    Report

    Report Number
    2029046-2023-00206
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 2, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: 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. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE FOLLOWED BY AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK REQUIRING PROLONGED HOSPITALIZATION. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING THE PROCEDURE, AN ADVERSE EVENT OCCURRED. THE INITIAL PULMONARY VEIN ISOLATION (PVI) PROCEDURE WAS SUCCESSFUL, HOWEVER, AN EP STUDY WAS STARTED, AND THE PHYSICIAN FOUND THEY HAD A "SLOW PATHWAY." A SLOW PATHWAY ABLATION WAS STARTED AND "THE PATIENT WENT INTO HEART BLOCK AND A TEMPORARY PACER HAD TO BE PUT IN." THE PATIENT WAS UNDER ANESTHESIA AND THERE WAS A DROPPED HEARTBEAT DURING THE SLOW PATHWAY ABLATION THE CALLER REPORTED A NON-CONDUCTED BEAT. FOLLOWING ABLATION, THE PATIENT CONTINUED TO HAVE NON-CONDUCTED BEATS. NO VENTRICULAR HEARTBEAT ON BOTH THE RECORDING SYSTEM AND THE CARTO 3 SYSTEM. A TEMPORARY PACEMAKER WAS INSERTED. SMARTTOUCH SF CATHETER AND SOUNDSTAR CATHETER AND WEBSTER'S CS CATHETER WERE ALL USED DURING THE PROCEDURE; HOWEVER, THEY DO NOT HAVE INFORMATION FOR ANY OF THESE CATHETERS. ALL THREE CATHETERS WERE IN THE BODY AT THE TIME OF THE ADVERSE EVENT. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS REPORTED AS PROCEDURE RELATED. INTERVENTION PROVIDED WAS A TEMPORARY PACEMAKER WIRE. PATIENT¿S OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. GENERATOR INFORMATION WAS A SMARTABLATE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955578 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H CARTO 3 SYSTEM| UNK_SOUNDSTAR| UNK_WEBSTER CS WITH AUTO ID