BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 23640887 · Received November 24, 2025

    Report

    Report Number
    2029046-2025-03899
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016741
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12-DEC-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHAEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A QDOT MICRO AND DAMAGE WAS FOUND ON THE SHAFT ABOUT 10 CM PROXIMAL FROM THE TIP. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION, FORCE AND MAGNETIC FUNCTIONALITY TEST OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SHAFT AND TIP WERE SEPARATED. EVIDENCE OF PROPER APPLICATION OF ADHESIVE WAS OBSERVED IN THE TRANSITION AREA FROM THE TIP TO THE SHAFT, HOWEVER, THE ADHESIVE WAS FOUND BROKEN, WHICH SUGGESTS EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. THE FORCE FEATURE WAS TESTED AND NO ERRORS WERE OBSERVED. THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. NO ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE SEPARATION OF THE SHAFT AND TIP COULD BE RELATED TO THE INTERNAL COMPONENTS EXPOSURE AND CAUSING FORCE AND MAGNETIC ISSUES REPORTED BY THE CUSTOMER, AS SUCH, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE OBSERVED COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE STERILE PACKAGING AND CATHETER SHOULD BE INSPECTED PRIOR TO USE. DO NOT USE IF THE PACKAGING OR CATHETER APPEARS DAMAGED; DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER MANIPULATION THROUGH THE SHEATH. 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE PHOTO DOES NOT PROVIDED SUFFICIENT INFORMATION RELATED TO THE FORCE AND MAGNETIC ISSUES REPORTED BY THE CUSTOMER; THEREFORE NO RESULTS CAN BE OBTAINED FOR THESE ISSUES. ALSO, THE TIP OF THE CATHETER WAS OBSERVED SEPARATED AT THE TIP TRANSITION WITH EXPOSED WIRES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. E1. INITIAL REPORTER PHONE: (B)(6). NOTE: H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (C22)¿ USED TO REPRESENT THE PHOTO ANALYSIS RESULTS. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHAEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A QDOT MICRO AND DAMAGE WAS FOUND ON THE SHAFT ABOUT 10 CM PROXIMAL FROM THE TIP. AFTER INSTALLING A 3RD DONGLE THEY CONNECTED THE QDOT MICRO, WHILE MAPPING WITH AN OPTRELL. THE CUSTOMER WAS VERY CAUTIOUS AND ALTHOUGH THE DONGLE LOOKED NORMAL (GREEN), EARLY IN THE PROCEDURE THE FOLLOWING ERRORS ON CARTO 3 SYSTEM THAT SWITCHED SEVERAL TIMES : 202, 105, 201, 210, 106, 996. ON THE NGEN THERE WAS NORMAL IMPEDANCE AND TEMPERATURE BUT ALSO THE FOLLOWING ERRORS: 170 (ELECTRODE TEMP FAULT), 273 AND A VERY STRANGE ONE , 276: CURRENTLY PACING ELECTRODE NUMBER 9 MICRON. THE NGEN WAS RESTARTED A FEW TIMES AND RESEATED ALL THE CONNECTIONS, BUT THE ERRORS KEPT ON COMING. THE DOCTOR DIDN'T WANT TO USE A NEW CABLE OR CATHETER AND THUS WE SWITCHED TO A SMARTTOUCH CATHETER. AFTER THE CASE , THE CALLER RECONNECTED THE QDOT MICRO WITH THE DONGLE (CATHETER WAS OUTSIDE THE PATIENT). ALTHOUGH THE DONGLE WAS COLORED GREEN THEY GOT THE FOLLOWING ERRORS ON THE CARTO 3 SYSTEM: 210 : ECO CABLE TEST FAILED , 105 : CATHETER SENSOR ERROR AND ON THE NGEN AGAIN THE ERROR 276: CURRENTLY PACING ELECTRODE 9 MICRON. AFTER THE PROCEDURE , THE QDOT MICRO WAS COLLECTED PHYSICAL DAMAGE WAS SEEN ON THE CATHETER. THE DAMAGE WAS DESCRIBED AS THE SHAFT WAS DAMAGED AND THE WIRES EXPOSED. THE DAMAGE WAS ON THE SHAFT ABOUT 10 CM PROXIMAL FROM THE TIP. AT THE SHAFT/HANDLE TRANSITION. NO RESISTANCE OR DIFFICULTY DURING THE INSERTION OR REMOVAL OF THE DEVICE WAS REPORTED. NO DAMAGE RESULTED IN LIFTED OR SHARP RINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528784 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31711220L 10846835016741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_CARTO 3| UNK_NGEN RF GENERATOR| UNK_OPTRELL MAPPING CATHETER| UNK_SMART TOUCH UNIDIRECTIONAL