BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 22119489 · Received May 30, 2025

    Report

    Report Number
    2134070-2025-00008
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    April 2, 2025
    Manufacturer
    STERILMED, INC.
    Product Code
    NLG
    UDI-DI
    10888551045179
    PMA / PMN Number
    K201806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE, 7F, 115CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND THE TWO SPINES WERE DAMAGED WITH CABLE EXPOSED. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE CATHETER COULDN'T CONNECT. IT COULDN¿T CONNECT TO THE CARTO 3 SYSTEM. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED EVENT REGARDING THE MAGNETIC SENSOR ERROR BEING DISPLAYED CANNOT BE EVALUATED THROUGH FUNCTIONAL TEST, SINCE THE DAMAGE NOTICED ON THE SPINES PREVENT THE ABILITY TO CONNECT THE DEVICE. WITH THE LIMITED INFORMATION AVAILABLE, THE ROOT CAUSE OF THE DAMAGES FOUND ON THE DEVICE REMAINS UNKNOWN. THERE IS NO INDICATION THAT THE ISSUE ENCOUNTERED IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE MANUFACTURE OF THE DEVICE. THE DAMAGE ON THE SPINES WAS NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THIS IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. AS PART OF STERILMED'S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% ELECTRICAL TESTING DURING REPROCESSING TO PREVENT SENSOR ISSUES FROM LEAVING THE FACILITY. 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 STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED 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 REF. NO:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER AND THE CARTO DISPLAYED ERROR 116 (MAGNETIC SENSOR ERROR) FOR THE CATHETER. THE CATHETER CABLE WAS REPLACED, AND THE ISSUE DID NOT RESOLVE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED FOR ANALYSIS, AND TWO SPINES WERE DAMAGED WITH CABLE EXPOSED. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21566 NA CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY, REPROCESSED NLG STERILMED, INC. 2183909 10888551045179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM| NGEN GENERATOR