BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19085861 · Received April 11, 2024

    Report

    Report Number
    2029046-2024-01190
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    February 27, 2024
    Report Date
    April 10, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE: (B)(6). 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 THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED ARRHYTHMIA THAT REQUIRED PACEMAKER IMPLANTATION. FIRST, IT WAS REPORTED THAT DURING FLUORO-GUIDED TRANSEPTAL PUNCTURE PERFORMED WITH A NON-BIOSENSE WEBSTER (BWI) NEEDLE ¿NOR SHEET¿, THE ASCENDING AORTA WAS PUNCTURED. AFTER A WAITING TIME OF 30 MINUTES, THE ELECTROCARDIOGRAM (ECG) AND TRANSESOFAGEAL ECHOCARDIOGRAPHY DID NOT REVEAL ANY COMPLICATION TO THE PATIENT AND THE PROCEDURE WAS RESUMED. DURING THE SAME PROCEDURE, WHILE DOING ABLATION OF THE POSTERIOR WALL WITH PULSED FIELD ABLATION (PFA BOSTON SCIENTIFIC), THE PATIENT LOST INTRINSIC ELECTRICAL CONDUCTION. SINUS RHYTHM WAS LOST BUT A JUNCTIONAL SPONTANEOUS RHYTHM RECOVERED TOWARDS THE END OF THE PROCEDURE. AT THE TIME, THE PHYSIOLOGICAL ELECTRICAL CONDUCTION WAS LOST. THERE WERE NO BIOSENSE WEBSTER CATHETERS PRESENT IN THE PATIENT¿S BODY. PACEMAKER IMPLANTATION WAS PLANNED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A BWI ABLATION CATHETER WAS USED AND THE ADVERSE EVENT WAS DISCOVERED DURING THE USE OF BWI PRODUCTS. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. PATIENT HAS IMPROVED AFTER EXTENDED HOSPITALIZATION DUE TO PACEMAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333873 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H CARTO3 EXTERNAL REFPATCH 6PACK| NON-BIOSENSE WEBSTER NEEDLE| SMARTABLATE GENERATOR KIT-WW