BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25178754 · Received May 14, 2026

    Report

    Report Number
    2029046-2026-01579
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: T. BATINIC ET AL. CATHETHER ABLATION OF PREMATURE VENTRICULAR COMPLEXES FROM THE LEFT VENTRICULAR SUMMIT COMPLICATED WITH ACUTE CORONARY SYNDROME; ACTA CLIN CROAT, VOL 64, NO 4, 2025; DOI: 10.20471/ACC.2025.64.04.21. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS 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. 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 LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: T. BATINIC ET AL. CATHETHER ABLATION OF PREMATURE VENTRICULAR COMPLEXES FROM THE LEFT VENTRICULAR SUMMIT COMPLICATED WITH ACUTE CORONARY SYNDROME; ACTA CLIN CROAT, VOL 64, NO 4, 2025; DOI: 10.20471/ACC.2025.64.04.21. BACKGROUND: PREMATURE VENTRICULAR COMPLEXES (PVCS) ARE ONLY CLINICALLY SIGNIFICANT IN A SMALL NUMBER OF PATIENTS. SYMPTOMS ARE USUALLY ACCOMPANIED BY A SIGNIFICANT PVCS BURDEN, WHICH CAN THEN CAUSE CARDIOMYOPATHY IN THE LONG TERM. CATHETER ABLATION IS THE THERAPY OF CHOICE IN THESE SITUATIONS. ONE OF THE MOST CHALLENGING FOCI IS THE AREA OF THE SO-CALLED LEFT VENTRICULAR SUMMIT (LV SUMMIT), DUE TO CLOSE ANATOMICAL CONNECTIONS AND CONSEQUENTLY A GREATER POSSIBILITY OF PERIPROCEDURAL COMPLICATIONS, INCLUDING INJURIES OF CORONARY ARTERIES. OBJECTIVE: THIS CASE REPORT SUGGESTS THAT IT SHOULD BE STANDARD PRACTICE TO RECORD A 12-CHANNEL ECG OF EVERY PATIENT IMMEDIATELY AFTER RETURNING TO THE WARD, REGARDLESS OF THE EXISTENCE OF ANY SYMPTOMS. CONSIDERING THE LOW RISK OF DIAGNOSTIC CORONARY ANGIOGRAPHY (<1%), WE BELIEVE THAT IT SHOULD BE ROUTINELY DONE BEFORE AND AFTER THE PLANNED ABLATION IN THE AREA OF THE LV SUMMIT. METHODS: A 66-YEAR-OLD FEMALE PATIENT WAS ADMITTED TO OUR DEPARTMENT FOR SCHEDULED CATHETER ABLATION OF SIGNIFICANT SYMPTOMATIC PVCS. ACCORDING TO THE LAST 24- HOUR HOLTER ECG, >20% MONOMORPHIC PVCS (LBBB, INFERIOR AXIS, TRANSITION AT V4) WERE OBSERVED DESPITE DRUG THERAPY WITH BISOPROLOL 7.5 MG ONCE DAILY (FIGURE 1). AS PART OF THE DIAGNOSTIC WORK-UP, A CORONARY ANGIOGRAPHY (WHICH WAS PERFORMED IN ANOTHER CENTER 1.5 YEARS BEFORE THE ABLATION) DID NOT REVEAL SIGNIFICANT STENOSIS OF THE CORONARY ARTERIES. AN ECHOCARDIOGRAPHIC EXAMINATION ALSO SHOWED NO ABNORMALITIES. UPON ARRIVAL AT OUR INSTITUTION, AN ELECTROPHYSIOLOGY STUDY (EPS) USING AN ELECTROANATOMIC MAPPING SYSTEM (CARTO, BIOSENSE-WEBSTER INC.) WAS PERFORMED VIA THE RIGHT TRANSVENOUS FEMORAL APPROACH. DURING THE PROCEDURE, FREQUENT CLINICAL PVCS WERE MONITORED. FIRST, THE RIGHT VENTRICULAR OUTFLOW TRACT WAS MAPPED WITH THE EARLIEST ACTIVATION (28MS) DURING PVCS IN THE POSTEROSEPTAL PART. RADIOFREQUENCY ENERGY (RFE) WAS APPLIED WITH AN 8FR 3.5MM TIP IRRIGATION CATHETER (30 W POWER MODE; MAXIMUM TEMPERATURE 48 °C, AT A FLOW RATE OF 17 ML/MIN; SMARTTOUCH THERMOCOOL, BIOSENSE-WEBSTER INC.) AFTER PVCS HAVE CHANGED MORPHOLOGY TO THE RBBB PATTERN. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. CONCLUSIONS: IN OUR CASE, BASED ON THE AFOREMENTIONED FACTS, WE THINK THAT THE UNDERLYING MECHANISM WAS PROBABLY THERMAL INJURY OF THE ENDOTHELIUM OF LCX, CAUSING ACUTE THROMBOSIS. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 8FR 3.5MM TIP IRRIGATION CATHETER (30 W POWER MODE; MAXIMUM TEMPERATURE 48 °C, AT A FLOW RATE OF 17 ML/MIN; SMARTTOUCH THERMOCOOL, BIOSENSE-WEBSTER INC.) OTHER BWI PRODUCTS: ELECTROANATOMIC MAPPING SYSTEM (CARTO, BIOSENSE-WEBSTER INC.) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 66-YEAR-OLD FEMALE PATIENT REPORTED ATYPICAL CHEST PAIN (BELOW THE LEFT SHOULDER BLADE) WITH ECG SHOWING ACUTE POSTEROLATERAL MYOCARDIAL INFARCTION WITH ST ELEVATION (FIGURE 3). AN URGENT CORONARY ANGIOGRAPHY WAS PERFORMED VIA THE RIGHT TRANSRADIAL APPROACH, WHICH SHOWED A THROMBOTIC OCCLUSION OF THE LEFT CIRCUMFLEX ARTERY (LCX) AT OSTIAL LEVEL (FIGURE 4) AND PCI WAS PERFORMED WITH THE IMPLANTATION OF ONE DRUG-ELUTING STENT (3.0/22MM), WHILE THE OTHER CORONARY ARTERIES WERE NORMAL. THE FINAL ANGIOGRAPHIC RESULT WAS OPTIMAL, WITH TIMI-3 FLOW. FURTHER POSTPROCEDURAL COURSE WAS NORMAL, WITH A SIGNIFICANT INCREASE IN HIGHLY SENSITIVE TROPONIN (HSTNI> 50,000 NG/L) AND ECHOCARDIOGRAPHY SHOWING A MILD HYPOKINESIA OF THE POSTEROLATERAL WALL WITH MAINTAINED WALL THICKNESS AND NORMAL SYSTOLIC FUNCTION (EF 50%). THE PATIENT WAS DISCHARGED 72 HOURS AFTER THE PROCEDURE WITH TELEMETRY FOLLOW-UP SHOWING NO RETURN OF PVCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593942 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| L| H