BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTABLATE

    MDR report key: 22129215 · Received June 2, 2025

    Report

    Report Number
    2029046-2025-01794
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009743
    PMA / PMN Number
    P990017/S17
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT AC9157423 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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 A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE IRRIGATION TUBE SET AND THE PACKAGING WAS OPEN. INITIALLY IT WAS REPORTED THAT THERE WAS A CONTAMINATED ITEM, BLOCKED PACKAGING. NO DAMAGE WAS CAUSED TO THE PATIENT. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED AND A RESPONSE WAS RECEIVED WHICH CLARIFIED IT WAS NOT FOREIGN MATERIAL. IT WAS JUST OPENED PACKAGING. THE TOP CORNER OF THE PACKAGING WAS OPEN. SINCE THE PACKAGING WAS OPEN, THEY CONSIDERED THE MATERIAL CONTAMINATED AND COULD NOT BE USED ON THE PATIENT. CALLER DOES NOT HAVE ANY IMAGES. THE ITEM WAS IDENTIFIED BY THE HOSPITAL. MATERIAL DISCARDED ACCORDING TO HOSPITAL PROTOCOL. MATERIAL WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362472 SMARTABLATE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC AC9157423 10846835009743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown