BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 21996753 · Received May 9, 2025

    Report

    Report Number
    2029046-2025-01498
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    January 24, 2025
    Report Date
    May 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED:NAKASONE K, DELLA ROCCA DG, MAGNOCAVALLO M, BETANCUR A, VETTA G, PANNONE L, SORGENTE A, AUDIAT C, RODRIGUEZ J, DOUNDOULAKIS I, NEKIC A, VELAGIC V, POLSELLI M, MOHANTY S, MARCON L, SIEIRA J, STRÖKER E, BALA G, BIANCHI S, ALMORAD A, COMBES S, TSIACHRIS D, SARKOZY A, NATALE A, BOVEDA S, ROSSI P, DE ASMUNDIS C, CHIERCHIA GB; HRMC INVESTIGATORS. PULSED FIELD ABLATION IN THE ELDERLY BY A PENTASPLINE MULTIELECTRODE CATHETER: SAFETY, EFFICACY, AND COMPARISON WITH CRYOBALLOON AND RADIOFREQUENCY DEVICES. HEART RHYTHM. 2025 JAN 24:S1547-5271(25)00094-3. DOI: 10.1016/J.HRTHM.2025.01.025. EPUB AHEAD OF PRINT. PMID: 39864479. 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 AND THE FOLLOWING CITATION WAS REVIEWED:NAKASONE K, DELLA ROCCA DG, MAGNOCAVALLO M, BETANCUR A, VETTA G, PANNONE L, SORGENTE A, AUDIAT C, RODRIGUEZ J, DOUNDOULAKIS I, NEKIC A, VELAGIC V, POLSELLI M, MOHANTY S, MARCON L, SIEIRA J, STRÖKER E, BALA G, BIANCHI S, ALMORAD A, COMBES S, TSIACHRIS D, SARKOZY A, NATALE A, BOVEDA S, ROSSI P, DE ASMUNDIS C, CHIERCHIA GB; HRMC INVESTIGATORS. PULSED FIELD ABLATION IN THE ELDERLY BY A PENTASPLINE MULTIELECTRODE CATHETER: SAFETY, EFFICACY, AND COMPARISON WITH CRYOBALLOON AND RADIOFREQUENCY DEVICES. HEART RHYTHM. 2025 JAN 24:S1547-5271(25)00094-3. DOI: 10.1016/J.HRTHM.2025.01.025. EPUB AHEAD OF PRINT. PMID: 39864479. BACKGROUND AND PURPOSE: BACKGROUND: CATHETER ABLATION IS AN EFFECTIVE TREATMENT OF ATRIAL FIBRILLATION. PULSED FIELD ABLATION (PFA) HAS EMERGED AS A NOVEL ENERGY MODALITY THAT RELIES ON HIGH-VOLTAGE ELECTRIC FIELDS TO ACHIEVE CARDIAC TISSUE ABLATION. DATA ON ITS EFFICACY IN THE ELDERLY ARE SCARCE. METHODS:CONSECUTIVE PATIENTS WITH ATRIAL FIBRILLATION >75 YEARS OLD UNDERGOING PFA WITH THE FARAPULSE SYSTEM WERE ENROLLED AT 6 HIGH-VOLUME CENTERS. PROCEDURAL DETAILS AND CLINICAL OUTCOMES WERE COMPARED WITH THOSE OF PATIENTS UNDERGOING SECONDGENERATION CRYOBALLOON ABLATION (CBA) AND RADIOFREQUENCY ABLATION (RFA). BWI DEVICES THAT WERE USED IN THIS STUDY: A 3-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEM (CARTO 3; BIOSENSE WEBSTER, DIAMOND BAR, CA), A MULTIPOLAR MAPPING CATHETER (PENTARAY OR OCTARAY; BIOSENSE WEBSTER)AND AN OPEN-IRRIGATED RFA CATHETER (THERMOCOOL SMARTTOUCH SURROUND FLOW OR Q-DOT; BIOSENSE WEBSTER). NON-BWI DEVICES: 3 ULTRASOUND-GUIDED RIGHT GROIN ACCESSES WERE USED TO ACHIEVE DOUBLE TRANSSEPTAL ACCESS THROUGH AN 8.5F SL0 FIXED SHEATH. A GROIN HEMATOMA COMPLICATION WAS REPORTED HOWEVER A NON BWI DEVICE WAS USED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT (QTY (B)(4). QTY 1 - STROKE (PERIPROCEDURAL COMPLICATIONS), NO REPORTED INTERVENTIO. QTY 3- CASES OF CARDIAC TAMPONADE (PERIPROCEDURAL COMPLICATIONS), NO REPORTED INTERVENTION. QTY 3- CASES OF PERSISTENT PHRENIC NERVE INJURY (PERIPROCEDURAL COMPLICATIONS) WERE OBSERVED, NO REPORTED INTERVENTION. QTY 7- PERICARDITIS (MINOR COMPLICATION), NO INTERVENTION PROVIDED. QTY 2- TRANSIENT PHRENIC NERVE(PN) INJURY (MINOR COMPLICATION), NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908628 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening