BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 20519163 · Received October 23, 2024

    Report

    Report Number
    2029046-2024-03461
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 23, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 31394117L 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. 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 A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED BRADYCARDIA AND HEART BLOCK THAT REQUIRED MEDICATION. AFTER THE CATHETER ABLATION PROCEDURE COMPLETION, BRADYCARDIA/CARDIAC BLOCK OCCURRED. BRADYCARDIA WAS RESOLVED BY DRUG ADMINISTRATION. AFTER SIX HOURS PASSED, SINUS RHYTHM RETURNED, AND THE PATIENT'S CONDITION SUBSIDED. THE PATIENT FULLY RECOVERED AND THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT AFTER THE PROCEDURE, WHEN THE SHEATH AND THE CATHETER WERE BEING REMOVED, THE CATHETER MIGHT HAVE HIT THE SITE NEAR THE SINUS NODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425728 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31394117L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention 8.5F SHEATH, VIZ SMCURVE,SHORT| NGEN PUMP, JAPAN CONFIGURATION| NGEN RF GENERATOR, JAPAN| OCTA,LNG,48P,3-3-3-3-3,D-CURVE| SOUNDSTAR ECO GE 8F CATHETER| UNK_CARTO 3