BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 20391086 · Received October 7, 2024

    Report

    Report Number
    2029046-2024-03307
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 8, 2023
    Report Date
    October 7, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KAUTZNER J, HA¿KOVÁ J, CVEK J, ADAMÍRA M, PEICHL P. HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WITH RECURRENT VENTRICULAR TACHYCARDIAS: FROM CATHETER ABLATION AND STEREOTACTIC RADIOTHERAPY TO HEART TRANSPLANT-A CASE REPORT. EUR HEART J CASE REP. 2024 JUL 30;8(8):YTAE379. DOI: 10.1093/EHJCR/YTAE379. PMID: 39144539; PMCID: PMC11322737. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: KAUTZNER J, HA¿KOVÁ J, CVEK J, ADAMÍRA M, PEICHL P. HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WITH RECURRENT VENTRICULAR TACHYCARDIAS: FROM CATHETER ABLATION AND STEREOTACTIC RADIOTHERAPY TO HEART TRANSPLANT-A CASE REPORT. EUR HEART J CASE REP. 2024 JUL 30;8(8):YTAE379. DOI: 10.1093/EHJCR/YTAE379. PMID: 39144539; PMCID: PMC11322737. OBJECTIVE/METHODS/STUDY DATA: MANAGEMENT OF HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY (HOCM) IS OFTEN CHALLENGING, DEPENDING ON CLINICAL MANIFESTATION. THIS CASE REPORT ILLUSTRATES THE COMPLEX TREATMENT OF HOCM WITH ASSOCIATED RECURRENT VENTRICULAR ARRHYTHMIAS. CASE SUMMARY: A 54-YEAR-OLD FEMALE WITH HOCM DIAGNOSED IN 2012 UNDERWENT A FAILED ATTEMPT FOR ALCOHOL SEPTAL ABLATION, IMPLANTATION OF AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, AND REPEATED RADIOFREQUENCY ABLATIONS (INCLUDING ABLATION OF THE SEPTAL BULGE TO REDUCE LV OBSTRUCTION). FOR VENTRICULAR TACHYCARDIA (VT) RECURRENCES, SHE HAD STEREOTACTIC ARRHYTHMIA RADIOABLATION WITH SUBSEQUENT EPICARDIAL CRYOABLATION FROM MINI-THORACOTOMY, AND ENDOCARDIAL ABLATION WITH PULSED FIELD ENERGY. THE SITUATION WAS FINALLY SOLVED BY MECHANICAL SUPPORT AND HEART TRANSPLANTATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH ABLATION CATHETER CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CENTAURI GENERATOR (GALVANIZE) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED SMARTTOUCH ABLATION CATHETER (QTY 1) (QTY 1) IN (B)(6) 2023, A 54-YEAR-OLD FEMALE PATIENT DEVELOPED A TRANSIENT ATRIOVENTRICULAR (AV) BLOCK DURING PULSED FIELD ENERGY ABLATION ON THE LATERAL WALL. AFTER A SERIES OF PULSED FIELD ENERGY APPLICATIONS, BIZARRE BROAD QRS COMPLEXES APPEARED, AND THE PATIENT BECAME HYPOTENSIVE WITH SEVERE LEFT VENTRICULAR DYSFUNCTION. LEAKAGE OF THE CURRENT THROUGH THE PROXIMAL ELECTRODES ON THE CATHETER SHAFT PLACED RETROGRADELY IN THE LEFT VENTRICLE IS A PROBABLE EXPLANATION FOR THIS COMPLICATION. THE PATIENT WAS THEN INTUBATED, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION, AND SUBSEQUENTLY, A COMPETITOR IMPELLA 5 (ABIOMED, INC.) WAS IMPLANTED, LEADING TO HAEMODYNAMIC STABILIZATION. VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION WAS EXPLANTED, AND THE PATIENT UNDERWENT AN ORTHOTOPIC HEART TRANSPLANT WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539413 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention CENTAURI GENERATOR (GALVANIZE)