BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18414241 · Received December 28, 2023

    Report

    Report Number
    2029046-2023-03109
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 30, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THERE WAS A CLOT THAT HAD FORMED. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS EXCHANGING SHEATHS, THE QDOT MICRO¿ CATHETER WAS DRAWN BACK WHERE IT WAS NOTICED ON THE QDOT TIP, IN-BETWEEN ELECTRODES TWO AND THREE, THERE WAS A CLOT THAT HAD FORMED. THE CATHETER WAS REPLACED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, TEMPERATURE, IMPEDANCE AND PATENCY TESTS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE IN ITS SURFACE. TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED, AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. A PATENCY TEST WAS PERFORMED, AND THE DEVICE WAS FLUSHING CORRECTLY. NO OBSTRUCTED HOLES WERE OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. BASED ON THE FINDINGS, THE PEBAX ISSUE MAY BE RELATED TO THE EVENT DESCRIBED BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31177540L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE EVALUATION DETERMINED THAT CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY (RF). IT CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING GUIDELINE: MONITORING THE TEMPERATURE FROM THE ELECTRODE DURING THE APPLICATION OF RF CURRENT ENSURES THAT THE IRRIGATION FLOW RATE IS BEING MAINTAINED. USING TIP TEMPERATURE TO GUIDE ABLATION COULD RESULT IN DEEPER LESIONS AND INCREASED RISK FOR COLLATERAL DAMAGE. DO NOT USE THE CATHETER WITHOUT IRRIGATION FLOW. MONITOR THE CATHETER TIP TEMPERATURE THROUGHOUT THE PROCEDURE TO ENSURE ADEQUATE IRRIGATION. IF THE TEMPERATURE INCREASES TO 40°C DURING RF APPLICATION, POWER DELIVERY SHOULD BE INTERRUPTED. RECHECK THE IRRIGATION SYSTEM PRIOR TO RESTARTING RF APPLICATION. THE ROOT CAUSE FOR THE PEBAX CONDITION MAY BE RELATED TO THE HANDLING OF THE DEVICE OUTSIDE THE MANUFACTURING FACILITIES; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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

    ON(B)(6)2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE 31177540L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. BASED ON THE COMPLETED MRE, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: PC-(B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND THERE WAS A CLOT THAT HAD FORMED. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS EXCHANGING SHEATHS, THE QDOT MICRO¿ CATHETER WAS DRAWN BACK WHERE IT WAS NOTICED ON THE QDOT TIP, IN-BETWEEN ELECTRODES TWO AND THREE, THERE WAS A CLOT THAT HAD FORMED. THE CATHETER WAS REPLACED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531405 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31177540L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK SHEATH