BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 25222401 · Received May 19, 2026

    Report

    Report Number
    2029046-2026-01608
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    January 26, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017052
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 QDOT MICRO APPROVED UNDER P210027. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND SCREENING TEST WERE PERFORMED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED. THE FORCE FEATURE WAS TESTED, AND NO ERRORS WERE OBSERVED. THE FORCE VALUES AND THE VECTOR WERE OBSERVED WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE FORCE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED, HOWEVER, THE HOLE ON THE PEBAX COULD BE RELATED TO THE FORCE ISSUE, THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE STATE: 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. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A VIZIGO CATHETER AND A 106 ALERT CODE OCCURRED AFTER THE CATHETER WAS PLUGGED INTO CARTO, AND BEFORE FIRST ABLATION (OUT-OF-BOX- FAILURE). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE CATHETER WAS NOT USED IN THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND SCREENING TEST WERE PERFORMED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487688 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31393271L 10846835017052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown