BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19661568 · Received July 2, 2024

    Report

    Report Number
    2029046-2024-02217
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. THE PERICARDIAL EFFUSION WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHILE THEY WERE MAPPING THE LEFT ATRIUM WITH THE PENTARAY CATHETER. THE PHYSICIAN CHECKED THE PERICARDIAL EFFUSION AND THEY SAW IT GROW VERY QUICKLY. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND IS BEING SENT TO THE ICU. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS, OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNING AND PRECAUTIONS: WHEN USING THE CATHETER WITH CONVENTIONAL SYSTEMS (USING FLUOROSCOPY TO DETERMINE CATHETER TIP LOCATION), OR WITH THE CARTO¿ 3 SYSTEM, CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED. THE FIRMNESS OF THE BRAIDED TIP DICTATES THAT CARE MUST BE TAKEN TO PREVENT PERFORATION OF THE HEART. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 1-JUL-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. THE PERICARDIAL EFFUSION WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHILE THEY WERE MAPPING THE LEFT ATRIUM WITH THE PENTARAY CATHETER. THE PHYSICIAN CHECKED THE PERICARDIAL EFFUSION AND THEY SAW IT GROW VERY QUICKLY. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND IS BEING SENT TO THE ICU. THE CALLER STATED THE PHYSICIAN THOUGHT THE PERICARDIAL EFFUSION MAY HAVE OCCURRED WHEN THE ABLATION CATHETER WAS INSERTED INTO THE CORONARY SINUS (CS) SINCE THEY THOUGHT THEY FELT A LITTLE RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552128 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31301831L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H UNK_PENTARAY