BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 24532565 · Received March 6, 2026

    Report

    Report Number
    2029046-2026-00739
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    December 27, 2025
    Report Date
    March 6, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017083
    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 THE QDOT MICRO APPROVED UNDER P210027. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. A FORCE TEST WAS PERFORMED, AND THE DEVICE WAS RECOGNIZED AND VISUALIZED CORRECTLY; HOWEVER, ERROR 106 DISPLAYED ON SCREEN. DUE TO THIS CONDITION, THE HANDLE OF THE DEVICE WAS DISSECTED, AND RESISTANCE OF THE SENSOR PADS ON THE PRINTED CIRCUIT BOARD (PCB) WAS MEASURED. THE RESULTS SHOW THAT IT WAS OUT OF SPECIFICATION. A DISSECTION WAS PERFORMED RIGHT AFTER AT THE TIP AREA, AND AN OPEN CIRCUIT WAS IDENTIFIED. IN ADDITION, FURTHER INVESTIGATION OF THE PEEK HOUSING SECTION REVEALED THAT THERE WAS INSUFFICIENT ADHESIVE (POLYURETHANE - PU) ON THE WIRES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE FORCE SENSOR ERROR COULD BE RELATED TO THE FORCE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE ADHESIVE CONDITION WAS TRACED TO THE MANUFACTURING PROCESS. THE PEBAX DAMAGE WAS NOT RELATED TO THE REPORTED EVENT, AND THE POTENTIAL CAUSE 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 INFORMATION: DO NOT SCRUB OR TWIST THE DISTAL TIP ELECTRODE DURING CLEANING. THE CONTACT FORCE READING MIGHT BECOME INACCURATE IF THE CONTACT FORCE SENSOR (LOCATED BETWEEN THE FIRST AND SECOND RING ELECTRODE) COMES INTO CLOSE PROXIMITY WITH A FERROUS MATERIAL, SUCH AS THE BRAIDED SHAFT OF ANOTHER CATHETER. IF EXTREME FLUCTUATIONS IN FORCE ARE OBSERVED, ENSURE THE CATHETER¿S CONTACT FORCE SENSOR IS NOT IN CLOSE PROXIMITY WITH ANOTHER CATHETER¿S SHAFT, CHECK ZERO ON THE CATHETER AND, IF NECESSARY, REMOVE AND INSPECT THE CATHETER. THE CONTACT FORCE READING IS FOR INFORMATION ONLY AND IS NOT INTENDED TO REPLACE STANDARD HANDLING PRECAUTION. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: OPEN CIRCUIT (C0205) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SENSOR (G03012) WERE SELECTED AS RELATED TO THE FORCE SENSOR ERROR WHICH IS RELATED TO THE FORCE ISSUE REPORTED BY THE CUSTOMER. INVESTIGATION FINDINGS: MANUFACTURING PROCESS PROBLEM IDENTIFIED (C16) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: ADHESIVE (G0405201) WERE SELECTED AS RELATED TO THE ADHESIVE CONDITION FOUND DURING DEVICE ANALYSIS. INVESTIGATION FINDINGS: MANUFACTURING PROCESS PROBLEM IDENTIFIED (C16) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: ADHESIVE (G0405201) WERE SELECTED AS RELATED TO THE ADHESIVE CONDITION FOUND DURING DEVICE ANALYSIS. INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE PEBAX DAMAGE. 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) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND DURING THE OPERATION, THERE WAS A PROBLEM WITH THE FORCE OF THE CATHETER. THE PRESSURE WAS NOT ACCURATE. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON 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 FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595062 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31730414L 10846835017083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown