BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18691637 · Received February 12, 2024

    Report

    Report Number
    2029046-2024-00473
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 19, 2024
    Report Date
    April 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016710
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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

    THE PICTURES WERE REVIEWED AND NO ROOT CAUSE CAN BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR ANALYSIS. THEREFORE, ONCE THE DEVICE IS RECEIVED BY THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB, THE EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2024-00473 FOR PRODUCT CODE D139501 (QDOT MICRO¿ CATHETER) (2) MFR # 2029046-2024-00474 FOR PRODUCT CODE D160903. (OCTARAY MAPPING CATHETER)

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE: (B)(6) 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) PRODUCT CODE D139501 (QDOT MICRO¿ CATHETER) (2) MFR # 2029046-2024-00474 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND AN OCTARAY MAPPING CATHETER AND CHAR WAS NOTED ON THE CATHETER WHEN IT WAS PULLED OUT FROM THE PATIENT. THE ABLATION WAS CONDUCTED IN THE LEFT AND RIGHT PULMONARY VEINS (PVS), AND DURING LEFT GAP ABLATION, WHEN THE QDOT MICRO¿ CATHETER WAS PULLED OUT FROM THE PATIENT¿S BODY, CHAR WAS CONFIRMED TO BE ATTACHED ON THE PROXIMAL SIDE OF THE IRRIGATION SECTION OF THE CATHETER. THE ABLATION BEHAVIOR WAS NORMAL, AND THE IRRIGATION FLOW WAS ADJUSTED AUTOMATICALLY BY THE NGEN GENERATOR. THERE WAS NO ERROR MESSAGE OBSERVED. THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. AFTER THE PROCEDURE WAS COMPLETED, WHEN THE CATHETER WAS PULLED OUT FROM THE PATIENT¿S BODY, CHAR WAS FOUND THAT WAS ATTACHED ON A PART OF THE ELECTRODE OF THE OCTARAY. THERE WAS NO PATIENT CONSEQUENCE. DURING THE PROCEDURE, THE OUTPUT POWER SUPPRESSION WAS NOT APPLIED MUCH. BULL¿S EYE WORKED NORMALLY. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PATIENT EXITED THE ROOM AS USUAL. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS. DURING THE PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. ACTIVATED CLOTTING TIME (ACT) VALUE WAS NOT KNOWN. THERE WAS NO COMMENT FROM THE PHYSICIAN ABOUT THE AMOUNT OF ADHERED SUBSTANCE TO BE EXCESSIVE BASED ON CLINICAL EXPERIENCE, ETC. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, TEMPERATURE, IMPEDANCE, AND PATENCY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO CHAR/THROMBUS/CLOT RESIDUES; HOWEVER, ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, CHAR WAS DETECTED. THE TEMPERATURE AND IMPEDANCE TEST WERE PERFORMED, AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. AFTERWARD, A PATENCY TEST WAS PERFORMED AND DURING THE TEST, SOME OF THE IRRIGATION HOLES WERE OBSERVED OCCLUDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31182174L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. ADDITIONALLY, THE MANUFACTURE AND EXPIRATION DATES HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. SINCE SOME OF THE IRRIGATION HOLES WERE FOUND OCCLUDED AND CHAR WAS CONFIRMED BY THE DECONTAMINATION LABORATORY, THE CUSTOMER COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. 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).

    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 AN OCTARAY MAPPING CATHETER AND CHAR WAS NOTED ON THE CATHETER WHEN IT WAS PULLED OUT FROM THE PATIENT. THE ABLATION WAS CONDUCTED IN THE LEFT AND RIGHT PULMONARY VEINS (PVS), AND DURING LEFT GAP ABLATION, WHEN THE QDOT MICRO¿ CATHETER WAS PULLED OUT FROM THE PATIENT¿S BODY, CHAR WAS CONFIRMED TO BE ATTACHED ON THE PROXIMAL SIDE OF THE IRRIGATION SECTION OF THE CATHETER. THE ABLATION BEHAVIOR WAS NORMAL, AND THE IRRIGATION FLOW WAS ADJUSTED AUTOMATICALLY BY THE NGEN GENERATOR. THERE WAS NO ERROR MESSAGE OBSERVED. THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. AFTER THE PROCEDURE WAS COMPLETED, WHEN THE CATHETER WAS PULLED OUT FROM THE PATIENT¿S BODY, CHAR WAS FOUND THAT WAS ATTACHED ON A PART OF THE ELECTRODE OF THE OCTARAY. THERE WAS NO PATIENT CONSEQUENCE. DURING THE PROCEDURE, THE OUTPUT POWER SUPPRESSION WAS NOT APPLIED MUCH. BULL¿S EYE WORKED NORMALLY. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PATIENT EXITED THE ROOM AS USUAL. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS. DURING THE PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. ACTIVATED CLOTTING TIME (ACT) VALUE WAS NOT KNOWN. THERE WAS NO COMMENT FROM THE PHYSICIAN ABOUT THE AMOUNT OF ADHERED SUBSTANCE TO BE EXCESSIVE BASED ON CLINICAL EXPERIENCE, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159457 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31182174L 10846835016710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN CONSOLE| NGEN PUMP, JAPAN CONFIGURATION| OCTA,LNG,48P,3-3-3-3-3,D-CURVE| UNK_CARTO 3| UNK_NGEN RF GENERATOR