BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE

    MDR report key: 12858609 · Received November 22, 2021

    Report

    Report Number
    2029046-2021-02021
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    August 10, 2021
    Report Date
    November 21, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835016758
    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 TO BIOSENSE WEBSTER FOR EVALUATION. BWI THEN CONDUCTED A VISUAL INSPECTION, GENERATOR TEST, AND CARTO 3 TEST THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED CATHETER REVEALED REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON THE SURFACE OF THE QDOT MICRO. VISUAL INSPECTION WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. IT WAS FOUND A HOLE AT THE PEBAX WITH REDDISH MATERIAL INSIDE IT. GENERATOR TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND NO IMPEDANCE ISSUES WERE DETECTED DURING THE ANALYSIS. CARTO 3 TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND NO FORCE ISSUES WERE DETECTED DURING THE ANALYSIS. HOWEVER, THE HOLE AT THE PEBAX WITH REDDISH MATERIAL INSIDE IT COULD BE RELATED TO THE FORCE ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BWI'S QUALITY PROCESS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER MANIPULATION THROUGH THE SHEATH. NOTE: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S078. (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE PEBAX DURING PRODUCT ANALYSIS. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER ABOUT 20 MINUTES SINCE DEVICE WAS INSERTED THE INTO THE CARDIAC CAVITY, CONTACT FORCE (CF) VALUE ABNORMALITY OCCURRED. ABNORMAL HIGH CF VALUE WAS DISPLAYED ON THE MONITOR, CABLE WAS CHANGED AND ZEROING WAS RECONDUCTED BUT THE ISSUE CONTINUED. THE QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE WAS CHANGED. WHEN THIS QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE WAS REMOVED FROM THE PATIENT¿S BODY, THE PEBAX PORTION WAS CONTAMINATED WITH BLOOD. THE CATHETER WAS CHANGED AND AFTER THAT, PROCEDURE WAS ENDED WITHOUT PROBLEM. AFTER THE CATHETER WAS CHANGED, THERE WAS ABLATION WITH A GRADUAL IMPEDANCE RISE DURING ABLATION, AS THROMBUS WAS SUSPECTED TO HAVE ADHERED, THE CATHETER WAS REMOVED FROM THE BODY, AND THE CONDITION OF THE TIP WAS VISUALLY CHECKED, BUT THERE WERE NO ABNORMALITIES, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE ABLATION NEVER CONTINUED BEYOND THE CUT-OFF VALUE. TEMPERATURE: 52¿, POWER: 45-35W, IMPEDANCE: 250O. IT WAS CONFIRMED THE PEBAX WAS NOT PHYSICALLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751962 QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE SIMILAR DEVICE D134801, PMA # P030031/S078 DRF BIOSENSE WEBSTER INC 30446697L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown QDOT MICRO, BI, TC, D-F