BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 18423054 · Received December 31, 2023

    Report

    Report Number
    2029046-2023-03128
    Event Type
    Malfunction
    Date Received
    December 31, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 31, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016710
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. INITIAL REPORTER PHONE: (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-03127 FOR PRODUCT CODE D139501 (QDOT MICRO). (2) MFR # 2029046-2023-03128 FOR PRODUCT CODE D139501 (QDOT MICRO).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH TWO QDOT MICRO CATHETERS AND SALINE SOLUTION DID NOT COME OUT SMOOTHLY AFTER FLUSHING. IT WAS REPORTED THAT WHEN FLUSHED, THE PROXY SIDE OF THE QDOT MICRO CATHETER DID NOT IRRIGATE PROPERLY. SALINE SOLUTION DID NOT COME OUT SMOOTHLY AFTER FLUSHING. TUBING WAS REATTACHED TO THE PUMP 3 TIMES. THE FIRST QDOT MICRO CATHETER WAS REPLACED, BUT THE PROBLEM PERSISTED, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31153098L AND NO NON-CONFORMANCES 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH TWO QDOT MICRO CATHETERS AND SALINE SOLUTION DID NOT COME OUT SMOOTHLY AFTER FLUSHING. IT WAS REPORTED THAT WHEN FLUSHED, THE PROXY SIDE OF THE QDOT MICRO CATHETER DID NOT IRRIGATE PROPERLY. SALINE SOLUTION DID NOT COME OUT SMOOTHLY AFTER FLUSHING. TUBING WAS REATTACHED TO THE PUMP 3 TIMES. THE FIRST QDOT MICRO CATHETER WAS REPLACED, BUT THE PROBLEM PERSISTED, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245810 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31153098L 10846835016710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NGEN RF GENERATOR