BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 22614499 · Received July 25, 2025

    Report

    Report Number
    2029046-2025-02447
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 21-JUL-2025. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH AN OPTRELL MAPPING CATHETER. IT WAS REPORTED THAT WHEN THE CATHETER WAS INSIDE OF THE BODY AND BEING STEERED BY THE PHYSICIAN, THE CATHETER WAS STUCK IN A CURVE EVEN THOUGH THE LOCK WAS NOT ON. THE DEVICE EVALUATION WAS COMPLETED ON 25-JUL-2025. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A DEFLECTION TEST WAS PERFORMED, AND THE DEVICE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION/STIFFNESS ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE DEFLECTION STUCK 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: USE THE ROCKER LEVER TO DEFLECT THE CATHETER TIP. WHEN THE LEVER IS TURNED OUT OF THE NEUTRAL POSITION, THE TIP DEFLECTS IN THE SAME DIRECTION AS THE LEVER. THE AMOUNT OF DEFLECTION IS RELATIVE TO THE AMOUNT OF LEVER ROTATION. TO STRAIGHTEN THE TIP, RETURN THE ROCKER LEVER TO NEUTRAL POSITION. AS PART OF JOHNSON AND 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 AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CURVE WAS STUCK. IT WAS REPORTED THAT WHEN THE CATHETER WAS INSIDE OF THE BODY AND BEING STEERED BY THE PHYSICIAN, THE CATHETER WAS STUCK IN A CURVE EVEN THOUGH THE LOCK WAS NOT ON. THE PHYSICIAN WAS UNABLE TO STRAIGHTEN OUT THE CATHETER. THE CATHETER WAS REMOVED FROM THE BODY AND WAS STILL STUCK IN THE CURVE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE FAULTY CATHETER WAS BRAND NEW. THE NGEN GENERATOR WAS USED FOR ABLATION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WOULD FULLY CONTRACT WITH A LOT MORE PRESSURE THAN NORMAL AND THEN WOULD STAY CONTRACTED ON ITS OWN. THEY WATCHED THIS HAPPEN ONCE IT WAS REMOVED FROM THE BODY. THE PHYSICIAN IS EXPERIENCED WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND FELT RIGHT AWAY WHEN CATHETER WAS PUT IN THAT IT WAS NOT PERFORMING NORMALLY. THE KNOB/PISTON WAS ABLE TO BE TURNED AND OR PUSHED UP AND DOWN BUT WITH A LOT OF FORCE. NO DIFFICULTY REMOVING THE CATHETER. NO RING, ELECTRODE NOR PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. SHEATH USED WAS THE CORDIS 9FR BRITE TIP 35CM CATALOG NUMBER: 401-935M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267691 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31335171M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CORDIS 9FR BRITE TIP 35CM.| UNK_NGEN RF GENERATOR.