BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 20560536 · Received October 29, 2024

    Report

    Report Number
    2029046-2024-03496
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31347746L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. 30 MINUTES AFTER THE PROCEDURE STARTED, IT WAS REPORTED THAT AFTER OBTAINING THE BS (BODY SURFACE) PATTERN MATCH, THE WAVEFORM OF THE OBTAINED PATTEN WAS SET IN THE PREFERENCE, BUT THE POI DID NOT APPEAR ON THE PATTERN VIEWER. THE MAP WAS RECREATED, BUT THE PROBLEM WAS REPRODUCED THREE TIMES. ON THE FOURTH MAP, THE POI APPEARED WITHOUT A PROBLEM. WHEN AN ABLATION CATHETER WAS INSERTED INTO THE CS (CORONARY SINUS) DURING PVC PROCEDURE (7 HOURS AFTER THE START OF THE PROCEDURE), CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS STOPPED, AND EFFUSION WAS CONFIRMED USING ECHOCARDIOGRAPHY. THE PATIENT'S LEVEL OF CONSCIOUSNESS WAS FINE. THE PATIENT'S BLOOD PRESSURE DROPPED FROM 130 TO AROUND 80. INTRACARDIAC DRAINAGE WAS PERFORMED. THE PATIENT IMPROVED HOWEVER REQUIRED EXTENDED HOSPITALIZATION TO MONITOR THE PATIENT'S CONDITION AFTER SURGERY AND AFTER PERICARDIAL DRAINAGE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. THEY BELIEVE DAMAGE OCCURRED DURING INSERTION OF THE CS CATHETER. ATRIAL SEPTAL PUNCTURE WAS PERFORMED WITH RF (RADIOFREQUENCY) NEEDLE. NO ABLATION OCCURRED PRIOR TO NOTING THE CARDIAC TAMPONADE. THE SURGERY REFERS TO THE ABLATION PROCEDURE. NO OPEN HEART SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922984 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31347746L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening| H| R 8.5F SHEATH, VIZ SMCURVE,SHORT| JPN CARTO 3 SYSTEM| OPTRELL, 36 ELECTRODES, D-F| RF_NEEDLE| SMARTABLATE GEN. KIT (JAPAN)| SMARTABLATE PUMP KIT (JAPAN)| SOUNDSTAR ECO SMS 8F CATHETER