BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 19606710 · Received June 25, 2024

    Report

    Report Number
    2029046-2024-02069
    Event Type
    Injury
    Date Received
    June 25, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: HEE, L.K., YAGISHITA, A., KITAZAWA, T., IIMURA, K., SAKAMA, S. (2024). HEART RHYTHM. TITLE: FEASIBILITY OF ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION USING A NOVEL TEMPERATURE-CONTROLLED ABLATION CATHETER; HTTPS://DOI.ORG/10.1016/J.HRTHM.2024.03.1139. 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: HEE, L.K., YAGISHITA, A., KITAZAWA, T., IIMURA, K., SAKAMA, S. (2024). HEART RHYTHM. TITLE: FEASIBILITY OF ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION USING A NOVEL TEMPERATURE-CONTROLLED ABLATION CATHETER; HTTPS://DOI.ORG/10.1016/J.HRTHM.2024.03.1139. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ABLATION INDEX (AI)-GUIDED PULMONARY VEIN ISOLATION (PVI) HAS BEEN WIDELY PERFORMED IN CATHETER ABLATION OF ATRIAL FIBRILLATION (AF). RECENTLY, A TEMPERATURE-CONTROLLED ABLATION CATHETER (QDOT MICRO, BIOSENSE WEBSTER, INC) HAD BEEN INTRODUCED, ENABLING VERY HIGH-POWER SHORT-DURATION (VHPSD) ABLATION. HOWEVER, FEASIBILITY OF AI-GUIDED PVI USING THE NOVEL CATHETER HAS NOT BEEN FULLY ELUCIDATED. OBJECTIVE(S): THIS STUDY AIMED TO DETERMINE THE FEASIBILITY AND SAFETY OF AI-GUIDED PVI USING THE QDOT MICRO. METHOD(S): IN THIS SINGLE-CENTER NON-RANDOMIZED PROSPECTIVE STUDY, CONSECUTIVE 140 PATIENTS UNDERGOING FIRST-TIME PVI WERE ENROLLED, WHO WERE DIVIDED IN TWO GROUPS: NON-QDOT GROUP (N=70); CONVENTIONAL AI-GUIDED PVI WITH A TARGET AI VALUE OF 350 TO 400 ON THE POSTERIOR WALL, ROOF AND BOTTOM (40 W), AND 450 ON THE ANTERIOR WALL (45 W), QDOT GROUP (N=70); VHPSD ON THE POSTEROINFERIOR WALL (90 W FOR 4 SECONDS), AND HIGH-POWER (50 W) TEMPERATURE-CONTROLLED ABLATION WITH SAME TARGET AI VALUES IN OTHER LESIONS. THE FIRST-PASS ISOLATION (FPI) RATE, MEAN PROCEDURAL TIME FOR BILATERAL PVI, ACUTE PV RECONNECTION RATE, AND COMPLICATIONS WERE COMPARED IN TWO GROUPS. RESULT(S): IN THE QDOT GROUP, THE FPI RATE, MEAN PROCEDURAL TIME FOR BILATERAL PVI, AND ACUTE PV RECONNECTION RATE WERE 91% (90% IN THE NON-QDOT GROUP, P=0.77), 28 +/- 11 MINUTES (35 +/- 9 IN THE NON-QDOT GROUP, P<0.0001), AND 5.7% (8.6% IN THE NON-QDOT GROUP, P=0.51), RESPECTIVELY. COMPLICATIONS OCCURRED IN TWO PATIENTS (2.9%) IN THE QDOT GROUP (PERICARDITIS AND INGUINAL HEMORRHAGE), WHEREAS ONE PATIENT (1.4%) PRESENTED CARDIAC TAMPONADE IN THE NON-QDOT GROUP (P=0.56). CONCLUSION(S): AI-GUIDED PVI IN COMBINATION WITH VHPSD ABLATION USING A NOVEL TEMPERATURE-CONTROLLED ABLATION CATHETER EFFICIENTLY PROVIDED FAVORABLE PROCEDURAL OUTCOMES WITHOUT COMPROMISING SAFETY. [FORMULA PRESENTED]COPYRIGHT © 2024 LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT 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. INGUINAL HEMORRHAGE IN THE QDOT GROUP IS ASSOCIATED WITH THE SHEATH USED FOR VASCULAR ACCESS, HOWEVER THE SHEATHS IDENTITY WAS NOT PROVIDED AND THEREFORE IS NOT CAPTURED IN THE CODING. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT: QTY 1 (PERICARDITIS) (RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807044 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other