BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 18927535 · Received March 18, 2024

    Report

    Report Number
    2029046-2024-00903
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    October 23, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017045
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: HUSSEIN AA, DELAUGHTER MC, MONIR G, NATALE A, DUKKIPATI S, OZA S, DAOUD E, DI BIASE L, MANSOUR M, FISHEL R, VALDERRABANO M, ELLENBOGEN K, OSORIO J; Q-FFICIENCY INVESTIGATORS. PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH A NOVEL TEMPERATURE-CONTROLLED CF-SENSING CATHETER: Q-FFICIENCY CLINICAL AND HEALTHCARE UTILIZATION BENEFITS. J CARDIOVASC ELECTROPHYSIOL. 2023 DEC;34(12):2493-2503. DOI: 10.1111/JCE.16093. EPUB 2023 OCT 23. PMID: (B)(4). NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUSSEIN AA, DELAUGHTER MC, MONIR G, NATALE A, DUKKIPATI S, OZA S, DAOUD E, DI BIASE L, MANSOUR M, FISHEL R, VALDERRABANO M, ELLENBOGEN K, OSORIO J; Q-FFICIENCY INVESTIGATORS. PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH A NOVEL TEMPERATURE-CONTROLLED CF-SENSING CATHETER: Q-FFICIENCY CLINICAL AND HEALTHCARE UTILIZATION BENEFITS. J CARDIOVASC ELECTROPHYSIOL. 2023 DEC;34(12):2493-2503. DOI: 10.1111/JCE.16093. EPUB 2023 OCT 23. PMID: 37870157. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: THE PROSPECTIVE, NONRANDOMIZED, MULTICENTER Q-FFICIENCY STUDY DEMONSTRATED THE SAFETY AND 12-MONTH EFFICACY OF PAROXYSMAL ATRIAL FIBRILLATION (AF) ABLATION WITH THE NOVEL QDOT MICRO TEMPERATURE-CONTROLLED, CONTACT FORCE-SENSING, RADIOFREQUENCY (RF) CATHETER. PARTICIPANTS UNDERWENT PULMONARY VEIN ISOLATION WITH VERY HIGH-POWER SHORT-DURATION (VHPSD) MODE (90 W, =4 S) ALONE OR COMBINED WITH CONVENTIONAL-POWER TEMPERATURE-CONTROLLED (CPTC) MODE (25-50 W). THIS STUDY AIMED TO ASSESS QUALITY-OF-LIFE (QOL) AND HEALTHCARE UTILIZATION (HCU) BENEFITS EXPERIENCED BY Q-FFICIENCY STUDY PARTICIPANTS. METHODS: BESIDES EVALUATING PROCEDURAL EFFICIENCY, QOL AND HCU WERE ASSESSED THROUGH 12 MONTHS POSTABLATION VIA ATRIAL FIBRILLATION EFFECT ON QUALITY-OF-LIFE TOOL (AFEQT) SCORE, ANTIARRHYTHMIC DRUG (AAD) USE, AND INCIDENCE OF CARDIOVERSION AND CARDIOVASCULAR HOSPITALIZATION. RESULTS: OF 191 PARTICIPANTS ENROLLED, 166 WERE ABLATED WITH THE NEW CATHETER. COMPARED TO BASELINE, STATISTICALLY SIGNIFICANT, CLINICALLY MEANINGFUL IMPROVEMENTS IN COMPOSITE AND SUBCATEGORIES OF AFEQT SCORES WERE OBSERVED AT 3 MONTHS AND SUSTAINED THROUGH 12 MONTHS (12-MONTH INCREASE, 29.3-44.2 POINTS). CLASS I/III AAD USE DECREASED FROM 97.6% (162/166) AT BASELINE TO 19.6% (31/158) DURING MONTHS 6-12, REPRESENTING A SIGNIFICANT 79.9% REDUCTION. THE CARDIOVERSION RATE SIGNIFICANTLY DECLINED BY 93.9% FROM 31.3% (12 MONTHS PREABLATION) TO 1.9% (EVALUATION PERIOD). ONE-YEAR KAPLAN-MEIER ESTIMATES OF FREEDOM FROM ALL-CAUSE AND CARDIOVASCULAR HOSPITALIZATION WERE 80.9% (95% CONFIDENCE INTERVAL [CI], 74.8%-86.9%) AND 88.8% (95% CI, 84.0%-93.7%), RESPECTIVELY. CONCLUSIONS: PAROXYSMAL AF ABLATION WITH THE NOVEL TEMPERATURE-CONTROLLED RF CATHETER IN VHPSD MODE, ALONE OR WITH CPTC MODE, LED TO CLINICALLY MEANINGFUL IMPROVEMENT IN QOL AND SIGNIFICANT REDUCTION IN AAD USE, CARDIOVERSION, AND CARDIOVASCULAR HOSPITALIZATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT ABLATION CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: N/A. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT ABLATION CATHETER: QTY 1 CASE OF (PERICARDIAL EFFUSION)(RECOGNIZED PROCEDURAL COMPLICATION). QTY 1 CASE OF (CARDIAC TAMPONADE)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553363 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835017045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening