BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 25178988 · Received May 14, 2026

    Report

    Report Number
    2029046-2026-01580
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    February 25, 2025
    Report Date
    May 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOMLÓSI F, NAGY KV, PERGE P, SALLÓ Z, OSZTHEIMER I, TANAI E, TÓTH P, ORBÁN G, FERENCZ AB, BOGA M, HIZOH I, PAPP V, HRITZ I, SZIJÁRTÓ A, BOUSSOUSSOU M, MERKELY B, GELLÉR L, SZEGEDI N. OESOPHAGEAL SAFETY OF HIGH AND VERY HIGH POWER SHORT DURATION PULMONARY VEIN ISOLATION: A RANDOMIZED COMPARISON OF THE 50 W AND 90 W POWER SETTINGS-THE HPSD OESOPHAGUS STUDY. EUR HEART J OPEN. 2026 FEB 25;6(2):OEAG041. DOI: 10.1093/EHJOPEN/OEAG041. PMID: 41918770; PMCID: PMC13033446. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOMLÓSI F, NAGY KV, PERGE P, SALLÓ Z, OSZTHEIMER I, TANAI E, TÓTH P, ORBÁN G, FERENCZ AB, BOGA M, HIZOH I, PAPP V, HRITZ I, SZIJÁRTÓ A, BOUSSOUSSOU M, MERKELY B, GELLÉR L, SZEGEDI N. OESOPHAGEAL SAFETY OF HIGH AND VERY HIGH POWER SHORT DURATION PULMONARY VEIN ISOLATION: A RANDOMIZED COMPARISON OF THE 50 W AND 90 W POWER SETTINGS-THE HPSD OESOPHAGUS STUDY. EUR HEART J OPEN. 2026 FEB 25;6(2):OEAG041. DOI: 10.1093/EHJOPEN/OEAG041. PMID: 41918770; PMCID: PMC13033446. BACKGROUND: POINT-BY-POINT RADIOFREQUENCY CATHETER ABLATION IS COMMONLY USED FOR PULMONARY VEIN ISOLATION (PVI) IN ATRIAL FIBRILLATION (AF). VERY HIGH POWER SHORT DURATION (VHPSD) TECHNOLOGY OFFERS SIMILAR EFFICACY TO HIGH POWER SHORT DURATION (HPSD) WITH REDUCED PROCEDURE TIMES. OBJECTIVE: THIS RANDOMIZED, SINGLE-CENTRE STUDY AIMED TO COMPARE THE THERMAL SAFETY OF VHPSD TO HPSD AND IDENTIFY ANATOMICAL AND BIOPHYSICAL PREDICTORS OF THERMAL INJURY. METHODS: BETWEEN FEBRUARY 2022 AND JUNE 2024, A TOTAL OF 148 PATIENTS. FORTY-EIGHT PATIENTS WITHDREW THEIR CONSENT BEFORE THE ENDOSCOPY. THIS REPORT PRESENTS THE PREDEFINED INTERIM ANALYSIS AFTER 100 PATIENTS UNDERWENT POST-PROCEDURE ENDOSCOPY. THE MEAN PATIENT AGE WAS 66 (55¿70), WITH 61% PAROXYSMAL AF; 61% OF THE PATIENTS WERE MALE. A FAST ANATOMICAL MAP WAS CREATED USING THE CARTO SYSTEM (BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA) AND A MULTIPOLAR MAPPING CATHETER (EITHER LASSO OR PENTARAY, BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA). AN IRRIGATED, CONTACT FORCE (CF) SENSING CATHETER (QDOT MICRO) AND A STEERABLE SHEATH (AGILIS, ABBOTT LABORATORIES, GREEN OAKS, ILLINOIS, USA) WERE UTILIZED IN ALL CASES TO CREATE CIRCUMFERENTIAL ANTRAL LESION SET AROUND THE IPSILATERAL PV¿S ORIFICE. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. CONCLUSIONS: PULMONARY VEIN ISOLATION USING VHPSD (90 W, 4 S) APPLICATIONS WAS NON-INFERIOR TO THE 50 W POWER SETTING IN THE CONTEXT OF THERMAL INJURY, DEFINED AS THE COMPOSITE OF POST-ABLATION OESOPHAGEAL LESIONS AND GASTRIC HYPOMOTILITY. A SMALLER ILD ON THE POSTERIOR WALL MAY NEGATIVELY IMPACT OESOPHAGEAL SAFETY. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED, CONTACT FORCE (CF) SENSING CATHETER (QDOT MICRO) OTHER BWI PRODUCTS: CARTO SYSTEM (BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA) AND A MULTIPOLAR MAPPING CATHETER (EITHER LASSO OR PENTARAY, BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA) NON-BWI DEVICES: A STEERABLE SHEATH (AGILIS, ABBOTT LABORATORIES, GREEN OAKS, ILLINOIS, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_QDOT MICRO DEVICE(S): QTY 3: 2 OESOPHAGEAL EROSIONS IN VHPSD GROUP AND 1 IN HPSD ARM WITH GASTRIC HYPOMOTILITY. ALL THE DETECTED EROSIONS WERE ASYMPTOMATIC AND RESOLVED WITHOUT SEQUELAE. QTY 11: 5 CASES OF GASTRIC HYPOMOTILITY IN VHPSD GROUP AND 6 ISOLATED GASTRIC HYPOMOTILITY IN HPSD WITH 1 CASE OCCURRED WITH AN OESPHAGEAL EROSION. CASES OF GASTROPARESIS WERE ALSO ASYMPTOMATIC AND DID NOT REQUIRE FASTING. QTY 2: 2 CASES OF PERICARDIAL TAMPONADE OCCURRED, ONE IN THE HPSD GROUP AND ONE IN THE VHPSD GROUP; BOTH WERE SUCCESSFULLY MANAGED BY PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353603 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening