BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 19922302 · Received August 6, 2024

    Report

    Report Number
    2029046-2024-02615
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    September 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017045
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    THE DEVICE EVALUATION WAS COMPLETED. SEE BELOW FOR THE EVALUATION DETAILS. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, AND FUNCTIONAL TESTS OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE TEMPERATURE AND IMPEDANCE TEST WERE 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31305534L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE TEMPERATURE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE STATES: WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE, OR MAY DAMAGE THE CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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

    ON 21-AUG-2024, IT WAS REPORTED THAT THE EVENT (TEMPERATURE ISSUE) TOOK PLACE ON (B)(6) 2024. AS SUCH, B 3. DATE OF EVENT HAS BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX INITIALLY, IT WAS REPORTED THAT AN ERROR APPEARED ON THE NGEN GENERATOR STATING: "STOP REASON: ELECTRODE TEMP SLOPE TOO HIGH." THE CABLE WAS EXCHANGED WITHOUT RESOLUTION. THE QDOT MICRO CATHETER WAS EXCHANGED, AND THE ERROR DID NOT RETURN ON THE NEXT RADIOFREQUENCY (RF) DELIVERY. CASE WAS CONTINUED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE TEMPERATURE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 10-JUL-2024, THERE WAS REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE HOLE IN THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 10-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674971 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31305534L 10846835017045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK CABLE.| UNK_NGEN RF GENERATOR.