BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO CATHETER

    MDR report key: 23916940 · Received December 29, 2025

    Report

    Report Number
    2029046-2025-04334
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Report Date
    December 29, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, FORCE, TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. DEVICE WAS CONNECTED TO CARTO 3 SYSTEM AND IT WAS RECOGNIZED CORRECTLY; HOWEVER, NO TEMPERATURE WAS DISPLAYED ON THE GENERATOR. ZEROING WAS PERFORMED AND FORCE VALUES AND VECTOR WERE DISPLAYED CORRECTLY. AN IRRIGATION TEST WAS PERFORMED AND THE DEVICE WAS IRRIGATING ADEQUATELY, NO IRRIGATION ISSUES WERE FOUND. DUE TO THE ERROR OBSERVED IN THE GENERATOR, DEVICE HANDLE WAS DISSECTED AND AN OPEN CIRCUIT WAS FOUND AT THE TIP AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31717863L AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT SCRUB OR TWIST THE TIP ELECTRODE AS DAMAGE TO THE TIP ELECTRODE BOND MAY OCCUR AND LOOSEN THE TIP ELECTRODE, OR DAMAGE MAY ALSO OCCUR TO THE CONTACT FORCE SENSOR AND AFFECT MEASUREMENT ACCURACY. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER, ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION. ANY SHEATH < 8.5 F IS CONTRAINDICATED. THE HIGH TEMPERATURE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT COULD NOT BE DETERMINED. THE NGEN GENERATOR USER MANUAL CONTAIN THE FOLLOWING INFORMATION: DO NOT USE TEMPERATURE SETTINGS HIGHER THAN THOSE RECOMMENDED IN THE INSTRUCTIONS FOR USE FOR THE CATHETERS. WHEN AN IRRIGATED CATHETER IS USED, THE TEMPERATURE MEASUREMENT REFLECTS THE TEMPERATURE OF THE COOLED IRRIGATED ELECTRODE, NOT THE TEMPERATURE OF THE TISSUE. THE TEMPERATURE OF THE TISSUE MAY BE DISTINCTLY HIGHER AND THE RISK OF STEAM POP MAY INCREASE. THE FORCE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: ALWAYS ZERO THE CONTACT FORCE READING FOLLOWING INSERTION OF THE CATHETER INTO THE PATIENT OR WHEN MOVING THE CATHETER FROM ONE CHAMBER OF THE HEART TO ANOTHER. ENSURE THE CATHETER IS NOT IN CONTACT WITH HEART TISSUE PRIOR TO ZEROING. DO NOT SCRUB OR TWIST THE TIP ELECTRODE BECAUSE DAMAGE TO THE TIP ELECTRODE BOND MAY OCCUR AND LOOSEN THE TIP ELECTRODE, OR DAMAGE THE CONTACT FORCE SENSOR AND AFFECT MEASUREMENT ACCURACY. REFER TO THE INSTRUCTIONS FOR USE FOR THE CARTO¿ 3 SYSTEM FOR INSTRUCTIONS ON HOW TO ZERO THE CONTACT FORCE READING. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, AFTER MAPPING A LITTLE WHILE WITH THE CATHETER, FORCE IS VERY HIGH (70-80G) EVEN WHEN NO TISSUE CONTACT WAS CONFIRMED. THE MEDICAL TEAM ALSO TRIED TO ABLATE, AND THE ABLATION IS STOPPED DUE TO HIGH TEMPERATURE. THE PHYSICIAN INSPECTED THE CATHETER AND SAW A BACKFLOW OF BLOOD IN THE PEBAX THAT COVERED THE TIP. THE CATHETER WAS EXCHANGED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847780 QDOT MICRO CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31717863L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown