BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 21794888 · Received April 8, 2025

    Report

    Report Number
    2029046-2025-01061
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 13, 2025
    Report Date
    May 5, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 13-APR-2025, THE PRODUCT INVESTIGATION WAS COMPLETED SINCE THE COMPLAINT DEVICE WAS NOT RETURNED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31481389L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A I QDOT MICRO¿ CATHETER AND EXPERIENCED JUNCTIONAL RHYTHM, RESULTING IN BRADYCARDIA DURING CARDIAC ABLATION PROCEDURE. IT WAS REPORTED THAT AFTER (PVI) PULMONARY VALVE ISOLATION COMPLETION, WHEN THE POSTERIOR WALL WAS ABLATED DURING (SVC) SUPERIOR VENA CAVA ISOLATION, THE SINUS RHYTHM CHANGED TO JUNCTIONAL RHYTHM, RESULTING IN BRADYCARDIA. THE PATIENT WENT INTO CARDIAC BLOCK, RESULTING IN BRADYCARDIA FROM ATRIOVENTRICULAR JUNCTIONAL RHYTHM. IT WAS REPORTED THAT IMMEDIATELY AFTER ABLATION TO THE POSTERIOR WALL DURING SVC ISOLATION, THE SINUS RHYTHM CHANGED TO JUNCTIONAL RHYTHM, WITH HEART RATE DROPPING TO THE 40-BPM RANGE AND RESULTING IN BRADYCARDIA. AN EXTERNAL PACEMAKER WAS INSERTED, AND THE PATIENT LEFT THE ROOM. SUBSEQUENT CONDITIONS ARE UNKNOWN. THE EVENT OCCURRED THREE HOURS AFTER THE START OF THE PROCEDURE, DURING SVC ISOLATION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION WAS REPORTED NOTED ON ADDITIONAL INFORMATION. CONTACT FORCE MONITORING METHOD USED WAS REAL TIME GRAPH, DASHBOARD, VECTOR WITH VISITAG COLOR SETTINGS OF TAG INDEX. CAUSAL RELATIONSHIP WITH THE PRODUCT WAS UNKNOWN. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO THE USE OF THE PRODUCT. ABLATION INFORMATION CONSISTED OF POWER 25W, TEMPERATURE 45 (36-48), CF 10G (5-14G), ABLATION TIME 22.12 SEC., IMPEDANCE DOWN 8 (108-100). THERE WERE ABNORMALITIES OBSERVED DURING THE USE OF THE PRODUCT. THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. THE EVENT DATE WAS 13-MAR-2025, AND THE EVENT OCCURRED DURING USED OF BWI PRODUCTS. THE PATIENT CONDITION IMPROVED, BECAUSE THE PATIENT MAY HAVE A RISK OF BRADYCARDIA RECURRENCE BY THE PATIENT¿S PROFESSION, A PACEMAKER IS SCHEDULED TO BE IMPLANTED AT THE PATIENT'S REQUEST. IT WAS REPORTED THAT THE PATIENT REQUIRED EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584026 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31481389L

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| L| H NGEN PUMP, JAPAN CONFIGURATION| NGEN RF GENERATOR, JAPAN| OCTA,LNG,48P,3-3-3-3-3,D-CURVE