BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21200580 · Received January 21, 2025

    Report

    Report Number
    2029046-2025-00238
    Event Type
    Injury
    Date Received
    January 21, 2025
    Report Date
    January 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): REAL-WORLD IMPACT OF STEERABLE SHEATHS FOR PAROXYSMAL ATRIAL FIBRILLATION CATHETER ABLATION: THE INSIGHT STUDY LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH, CARTO® 3 EP NAVIGATION SYSTEM, THERMOCOOL SMARTTOUCH SF, PENTARAY, LASSO. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: VIZIGO GROUP: 1 PATIENTS HAD COMPRISED CARDIAC TAMPONADE/PERICARDIAL EFFUSION. 2 PATIENTS HAD COMPROMISED MAJOR VASCULAR ACCESS/BLEEDING. 1 PATIENTS HAD COMPROMISED THROMBOEMBOLISM (WHO ALSO EXPERIENCED MAJOR VASCULAR ACCESS/BLEEDING). NON-VIZIGO GROUP: 1 PATIENTS HAD COMPRISED CARDIAC TAMPONADE/PERICARDIAL EFFUSION. 4 PATIENTS HAD COMPROMISED MAJOR VASCULAR ACCESS/BLEEDING. THERE WERE NO REPORTS OF ATRIOESOPHEAGEAL FISTULA, PHRENIC NERVE PARALYSIS/INJURY, SEVERE PULMONARY VEIN STENOSIS, STROKE, TRANSIENT ISCHEMIC ATTACK, MYOCARDIAL INFARCTION, PERICARDITIS, OR VAGAL NERVE INJURY. NO PROCEDURE-RELATED DEATHS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669675 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening AGILIS SHEATH| UNKNOWN ABLATION CATHETER| UNKNOWN SHEATH| UNK_C3 CS REFSTAR - DEFLECTABLE| UNK_CARTO 3| UNK_CARTO VIZIGO SHEATH| UNK_LASSO NAV ECO| UNK_PENTARAY NAV ECO| UNK_SOUNDSTAR ECO| UNK_WEBSTER CS WITH AUTO ID