BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 21719725 · Received March 28, 2025

    Report

    Report Number
    2029046-2025-00949
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    October 18, 2023
    Report Date
    March 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: BORTONE AA, RAMIREZ FD, CONSTANTIN M, BORTONE C, HÉBERT C, CONSTANTIN J, BIALAS P, LIMITE LR. OPTIMAL INTERLESION DISTANCE FOR 90 AND 50 WATT RADIOFREQUENCY APPLICATIONS WITH LOW ABLATION INDEX VALUES: EXPERIMENTAL FINDINGS IN A CHRONIC OVINE MODEL. EUROPACE. 2023 NOV 2;25(11):EUA(B)(4). DOI: 10.1093/EUROPACE/EUA(B)(4). PMID: 37851513; PMCID: PMC10629717. 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. E1. INITIAL REPORTER PHONE: (B)(6). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: BORTONE AA, RAMIREZ FD, CONSTANTIN M, BORTONE C, HÉBERT C, CONSTANTIN J, BIALAS P, LIMITE LR. OPTIMAL INTERLESION DISTANCE FOR 90 AND 50 WATT RADIOFREQUENCY APPLICATIONS WITH LOW ABLATION INDEX VALUES: EXPERIMENTAL FINDINGS IN A CHRONIC OVINE MODEL. EUROPACE. 2023 NOV 2;25(11):EUA(B)(4). DOI: 10.1093/EUROPACE/EUA(B)(4). PMID: 37851513; PMCID: PMC10629717. OBJECTIVE: THE OBJECTIVE OF THE PRESENT EXPERIMENTAL STUDY WAS TO DETERMINE THE OPTIMAL ILD FOR BOTH 90 W¿4 S AND 50 W RF APPLICATIONS IN THE ATRIA WHEN TARGETING LOW AI VALUES. THIS INFORMATION CAN POTENTIALLY HELP TO SAFELY CREATE DURABLE ENCIRCLEMENTS (OR LINES) AND, THEREBY, IMPROVE PVI AND OVERALL CATHETER ABLATION OUTCOMES IN HUMANS. METHODS: POSTERIOR INTERCAVAL LINES WERE CREATED IN EIGHT ADULT SHEEP USING CARTO AND THE QDOT-MICRO CATHETER IN A TEMPERATURE-CONTROLLED MODE. IN FOUR ANIMALS, THE LINES WERE CREATED WITH 50 W APPLICATIONS, A TARGET AI VALUE =350, AND ILDS OF 6, 5, 4, AND 3 MM, RESPECTIVELY. IN THE OTHER FOUR ANIMALS, THE LINES WERE CREATED WITH 90 W¿4 S APPLICATIONS AND ILDS OF 6, 5, 4, AND 3 MM, RESPECTIVELY. ACTIVATION MAPS WERE CREATED IMMEDIATELY AFTER ABLATION AND AT 21 DAYS TO ASSESS LINEAR BLOCK PRIOR TO GROSS AND HISTOLOGICAL ANALYSES. ALL EIGHT LINES APPEARED TRANSMURAL AND CONTINUOUS ON HISTOLOGY. HOWEVER, FOR 50 W-ONLY APPLICATIONS WITH AN ILD OF 3 MM RESULTED IN DURABLE LINEAR ELECTRICAL BLOCK, WHEREAS FOR 90 W APPLICATIONS, ONLY THE LINES WITH ILDS OF 4 AND 3 MM WERE BLOCKED. CONCLUSIONS: IN THE INTERCAVAL REGION IN SHEEP, FOR 50 W APPLICATIONS WITH AN AI VALUE OF ~370, THE OPTIMAL ILD IS 3 MM, WHEREAS FOR 90 W¿4 S APPLICATIONS, THE OPTIMAL ILD IS 3¿4 MM. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT-MICRO ABLATION CATHETER (BIOSENSE WEBSTER). OTHER BWI PRODUCTS: (CARTO 3, BIOSENSE WEBSTER, IRVINE, CA, USA), PENTARAY CATHETER (BIOSENSE WEBSTER) AND NGEN RF V1C GENERATOR (BIOSENSE WEBSTER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH QDOT MICRO ABLATION CATHETER: QTY 8: 4 SHEEP HAD COLLATERAL THERMAL INJURIES WERE CONSISTENTLY OBSERVED ON THE LUNG SURFACE WITH 90 W¿4 S RF APPLICATIONS IRRESPECTIVE OF THE TARGETED ILD. 3 SHEEP HAD SIMILAR LUNG LESIONS WERE OBSERVED WITH 50 W AI-GUIDED RF APPLICATIONS FOR ALL ILDS EXCEPT FOR 6 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579553 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3.| NGEN GENERATOR.| PENTARAY CATHETER.