BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 22189405 · Received June 11, 2025

    Report

    Report Number
    2029046-2025-01912
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SUGA K, KATO H, YAMAZAKI K, SAKURAI T, OTA R, OTA T, MURAKAMI H, KADA K, TSUBOI N, YANAGISAWA S, INDEN Y, MUROHARA T. CHAR FORMATION DURING VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2025 MAY 9. DOI: 10.1111/JCE.16707. EPUB AHEAD OF PRINT. PMID: 40345992. 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. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SUGA K, KATO H, YAMAZAKI K, SAKURAI T, OTA R, OTA T, MURAKAMI H, KADA K, TSUBOI N, YANAGISAWA S, INDEN Y, MUROHARA T. CHAR FORMATION DURING VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2025 MAY 9. DOI: 10.1111/JCE.16707. EPUB AHEAD OF PRINT. PMID: 40345992. OBJECTIVE/METHODS/STUDY DATA: ABSTRACT. INTRODUCTION: PULMONARY VEIN (PV) ISOLATION USING VERY HIGH-POWER SHORT-DURATION (VHPSD) RADIOFREQUENCY CATHETER ABLATION IS AN EFFECTIVE TREATMENT STRATEGY FOR ATRIAL FIBRILLATION. HOWEVER, PV ISOLATION USING VHPSD ABLATION (VHPSD-PVI) CARRIES A POTENTIAL RISK OF CHAR FORMATION. WE AIMED TO ASSESS THE INCIDENCE, PATIENT CHARACTERISTICS, AND PROCEDURAL FACTORS OF CHAR FORMATION DURING VHPSD-PVI. METHODS AND RESULTS: FIFTY CONSECUTIVE PATIENTS SCHEDULED TO UNDERGO INITIAL PV ISOLATION (PVI) WERE PROSPECTIVELY INCLUDED. PVI WAS PERFORMED USING A QDOT MICROTM CATHETER IN THE VHPSD SETTING (90W/4 S). PVS WERE DIVIDED INTO EIGHT SEGMENTS, AND CHAR FORMATION AROUND THE ABLATION CATHETER WAS EVALUATED AFTER THE ABLATION OF EACH SEGMENT. PATIENT CHARACTERISTICS AND PROCEDURAL PARAMETERS WERE ANALYZED TO DETERMINE THE RISK FACTORS FOR CHAR FORMATION. DURING VHPSDPVI, CHAR FORMATION WAS OBSERVED IN 24 (48.0%) PATIENTS, PRIMARILY AT THE GROOVE BETWEEN THE TIP AND RING ELECTRODES. AMONG THE SEGMENTS, THE INCIDENCE OF CHAR FORMATION WAS THE HIGHEST (26.0%) IN THE ANTERIOR AND POSTERIOR RIGHT INFERIOR PV (RIPV) SEGMENTS (P < 0.001). ONE PATIENT WITH CHAR FORMATION DEVELOPED SYMPTOMATIC THROMBOEMBOLISM AFTER THE PROCEDURE. THE LEFT ATRIAL VOLUME INDEX (LAVI) (ODDS RATIO [OR], 1.089; 95% CONFIDENCE INTERVAL [CI], 1.011¿1.173; P = 0.024) AND PARALLEL CATHETER ORIENTATION (OR, 1.592; 95% CI, 1.416¿1.791; P < 0.001) WERE INDEPENDENT PREDICTORS OF CHAR FORMATION. CONCLUSION: CHAR FORMATION OCCURRED IN 48.0% OF THE PATIENTS DURING VHPSD-PVI. APPLICATION TO THE RIPV SEGMENT, A HIGHER LAVI, AND PARALLEL CATHETER ORIENTATION WERE ASSOCIATED WITH AN INCREASED RISK OF CHAR FORMATION, INDICATING THAT VHPSD APPLICATIONS SHOULD BE AVOIDED UNDER THESE CONDITIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT MICRO. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO, OCTARAY, NGEN RF GENERATOR. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILIS NXT AND SWARTZ BRAIDED SL0 (ABBOTT, ABBOTT PARK, IL, USA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT MICRO: QTY 1 ¿ (THROMBOSIS)(CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION)/(ADVERSE EVENT) (CHAR)(THROMBUS/CLOT). ONE PATIENT WITH HISTORY OF PERSISTENT ATRIAL FIBRILLATION, HEART FAILURE AND HYPERTENSION WITH A CHADS SCORE OF 3 EXHIBITED CHAR FORMATION AT THE CATHETER TIP AND DEVELOPED SYMPTOMATIC THROMBOEMBOLISM AFTER THE PROCEDURE. EIGHT HOURS POST PROCEDURE, THE PATIENT DEVELOPED LEFT-SIDED HEMIPARESIS. BRAIN MRI REVEALED A NEW-ONSET CEREBRAL INFARCTION IN THE RIGHT MIDDLE CEREBRAL ARTERY PERFORATOR TERRITORY. DESPITE MEDICATION (EDARAVONE INFUSION AND CONTINUED DOAC [DIRECT ORAL ANTICOAGULANT] THERAPY), THE HEMIPARESIS PERSISTED. CHAR FORMATION WAS CONFIRMED FOLLOWING THE 11 RF APPLICATIONS TO THE ANTERIOR RIPV SEGMENT (SEGMENT 7), WITH FIVE AND SIX CASES OCCURRING IN OBLIQUE AND PARALLEL CATHETER ORIENTATION, RESPECTIVELY. DEVICE RELATED ISSUE ASSOCIATED WITH UNIDENTIFIED QDOT MICRO: QTY 23 ¿ (NO SIGNS, SYMPTOMS OR PATIENT INVOLVMENT) (NO PATIENT CONSEQUENCE)/(CHAR)(THROMBUS/CLOT). CHAR FORMATION WAS OBSERVED IN 24 (48.0%) PATIENTS: 23 (46.0%) AROUND THE ABLATION CATHETER TIP AND 11 (22.0%) IN BLOOD ASPIRATED FROM THE SHEATH. TEN (20.0%) PATIENTS EXHIBITED CHAR FORMATION BOTH AT THE CATHETER TIP AND IN ASPIRATED BLOOD. IN THE CHAR GROUP, 13 (54.2%) PATIENTS EXHIBITED CHAR FORMATION IN MULTIPLE PV SEGMENTS. ALL CLOTS WERE OBSERVED AT THE JUNCTIONAL GROOVE BETWEEN THE TIP AND RING ELECTRODES OF THE ABLATION CATHETER, EXCEPT FOR ONE PATIENT IN WHOM CHAR WAS FORMED ON THE DISTAL TIP ELECTRODE. NOTABLY, CHAR FORMATION WAS OBSERVED EXCLUSIVELY DURING VHPSD-PVI AND DID NOT OCCUR DURING ADDITIONAL ABLATION PERFORMED NDER NON-VHPSD SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86792 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_CARTO 3| UNK_NGEN RF GENERATOR| UNK_OCTARAY NAV| UNK_QDOT MICRO