BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18784697 · Received February 26, 2024

    Report

    Report Number
    2029046-2024-00645
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    November 6, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BIOSENSE WEBSTER (BWI) CONDUCTED A VISUAL INSPECTION AND SCREENING TEST OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED REDDISH BROWN MATERIAL INSIDE AND A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED. THE MAGNETIC AND FORCE FEATURE WAS TESTED, AND NO ERRORS WERE OBSERVED. THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. NO FORCE ISSUES WERE OBSERVED. THE FORCE ISSUE DESCRIBED WAS UNABLE TO BE DUPLICATED DURING THE PRODUCT INVESTIGATION HOWEVER, THE BLOOD INSIDE THE PEBAX AREA FOUND COULD BE RELATED TO THE REPORTED ISSUE AS A POTENTIAL CAUSE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. E1. INITIAL REPORTER PHONE: 058-277-2277 IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # PC-001474903

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A REDDISH BROWN MATERIAL INSIDE AND A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS A CONTACT FORCE ERROR AND THE PATIENT INTERFACE UNIT (PIU) AND THE NGEN GENERATOR WERE RESTARTED BUT THE ISSUE WAS NOT RESOLVED. THEY CHANGED TO CRYO AND REPLACED THE LAN CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629965 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31105502L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8.5F SHEATH WITH CURVE VIZ MDC.| NGEN RF GENERATOR, JAPAN.