BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 22186175 · Received June 11, 2025

    Report

    Report Number
    2029046-2025-01895
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    March 30, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ON 4-JUL-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND AFTER ABLATION, THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE EXACT LOCATION OF THE CHARRING WAS BETWEEN TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. NO ERROR MESSAGES, TEMPERATURE ISSUES, OR FLOW ISSUES PRECEDED THE CHAR ISSUE. THERE WAS NO EXCESSIVE FORCE OR ABLATION TIMES USED. THE PHYSICIAN AIMED FOR 5-15 GRAMS OF FORCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION, TEMPERATURE AND IMPEDANCE, AND IRRIGATION TESTS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SHAFT WAS BENT. TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED, AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. AN IRRIGATION 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 31448618L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CHAR AND THROMBUS ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE BENT SHAFT CONDITION COULD BE RELATED TO THE HANDLING/SHIPPING OF THE DEVICE AFTER THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE BENT SHAFT IS UNRELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: WHEN RF (RADIOFREQUENCY) ENERGY IS INTERRUPTED FOR EITHER A TEMPERATURE OR AN IMPEDANCE RISE (THE SET LIMIT IS EXCEEDED), THE CATHETER SHOULD BE REMOVED, AND THE TIP SHOULD BE INSPECTED FOR CHAR/COAGULUM THAT MAY BE PRESENT ON THE TIP. IF PRESENT, DO NOT CONTINUE THE PROCEDURE WITH THE SAME CATHETER AND REPLACE THE CATHETER. IF NO CHAR/COAGULUM IS PRESENT, FLUSH THE TIP TO ENSURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO REINSERTION OF THE CATHETER INSIDE THE PATIENT BODY. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT COMPLAINT WILL BE ADDRESSED THROUGH THE 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 A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND AFTER ABLATION, THE DOCTOR NOTICED SOME CHARRING ABOVE THE ELECTRODE. THE EXACT LOCATION OF THE CHARRING WAS BETWEEN TIP ELECTRODE AND ELECTRODE 2 AT THE PLASTIC RING SEPARATING THE ELECTRODES. NO ERROR MESSAGES, TEMPERATURE ISSUES, OR FLOW ISSUES PRECEDED THE CHAR ISSUE. THERE WAS NO EXCESSIVE FORCE OR ABLATION TIMES USED. THE PHYSICIAN AIMED FOR 5-15 GRAMS OF FORCE. THE GENERATOR PARAMETERS WERE AS FOLLOWS: ¿ QMODE+ ¿ 90W ¿ TEMPERAURE TARGET: 55°C ¿ TEMPERATURE CUT OFF: 65°C THE PATIENT WAS ANTICOAGULATED WITH AN ACT (ACTIVATED CLOTTING TIME) OF >300, A VALUE WHICH WAS MAINTAINED THROUGHOUT THE CASE. THE IRRIGATION FLUID USED WAS HEPARINIZED NORMAL SALINE. THE PHYSICIAN DEEMED THE CHARRING PRESENT TO BE AN INCREASED RISK TO THE PATIENT. HOWEVER, NO PATIENT CONSEQUENCES WERE REPORTED. THERE WERE NO POST PROCEDURAL NEUROLOGICAL ISSUES AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90436 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31448618L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN PUMP, EU CONFIGURATION| NGEN RF GENERATOR