BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 19864003 · Received July 30, 2024

    Report

    Report Number
    2029046-2024-02543
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QDOT MICRO DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, AND SCREENING TEST EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE FORCE FEATURE WAS TESTED, AND NO ERRORS WERE OBSERVED. THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. NO FORCE ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31305624L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE FORCE AND VISUALIZATION 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: USING ASEPTIC TECHNIQUE, REMOVE THE CATHETER FROM THE PACKAGE AND PLACE IT IN A STERILE WORK AREA. INSPECT THE CATHETER CAREFULLY FOR ELECTRODE INTEGRITY AND OVERALL CONDITION. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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 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 THE QDOT MICRO¿ CATHETER WOULD NOT SYNC WITH THE VIZIGO¿ SHEATH. THE CABLE FOR THE VIZIGO¿ SHEATH WAS REPLACED AND THE ISSUE WAS NOT RESOLVED. THE CATHETER CABLE WAS REPLACED, AND THE ISSUE CONTINUED. UPON ABLATION WAS STARTED, THE CATHETER LOST THE FORCE VALUES, DISPLAYED HIGH FORCE, AND JUMPED ON THE SCREEN. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FORCE AND VISUALIZATION ISSUES WERE 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 02-JUL-2024, THERE WAS A HOLE IN THE SURFACE OF THE PEBAX. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 02-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281160 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31305624L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK CABLE FOR SHEATH| UNK CATHETER CABLE| UNK_CARTO VIZIGO SHEATH| UNK_NGEN RF GENERATOR