BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 19140593 · Received April 18, 2024

    Report

    Report Number
    2029046-2024-01298
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). 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

    ON 6-MAY-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IRRIGATION WAS NOT COMING OUT OF THE TIP LUMEN. PUMP WAS NOT USED. IT WAS DRIPPED UNDER PRESSURE. IT WAS COMING OUT AT THE BEGINNING OF THE PROCEDURE BUT CEASED WHEN SWITCHING CATHETERS AFTER PRE-MAPPING. NO OPTRELL CATHETER SETTINGS WERE INSTALLED ON THE GENERATOR. THE ISSUE WAS RESOLVED BY REPLACING THE OPTRELL TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO ANOMALIES OR DAMAGES IN THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND DURING THE TEST, AN OCCLUSION WAS DETECTED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBE WAS BENT CLOSE TO THE TIP SECTION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31182872M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. SINCE THE IRRIGATION TUBE WAS FOUND BENT CLOSE TO THE TIP SECTION, THIS FAILURE COULD BE RELATED TO THE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE BENT CONDITION OBSERVED COULD NOT BE DETERMINED. AS PART OF BIOSENSE WEBSTER¿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 ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IRRIGATION WAS NOT COMING OUT OF THE TIP LUMEN. PUMP WAS NOT USED. IT WAS DRIPPED UNDER PRESSURE. IT WAS COMING OUT AT THE BEGINNING OF THE PROCEDURE BUT CEASED WHEN SWITCHING CATHETERS AFTER PRE-MAPPING. NO OPTRELL CATHETER SETTINGS WERE INSTALLED ON THE GENERATOR. THE ISSUE WAS RESOLVED BY REPLACING THE OPTRELL TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408340 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31182872M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown