BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 24029734 · Received January 9, 2026

    Report

    Report Number
    2134070-2026-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 16, 2025
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551045094
    PMA / PMN Number
    K161700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED; THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 2244101 WAS REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTIONS, ALL FINISHED GOODS¿ PRODUCTS HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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 FLUTTER ABLATION PROCEDURE AND THERE WAS A FOREIGN SUBSTANCE INSIDE THE STERILE PACKAGING OF THE REPROCESSED STERILMED SOUNDSTAR CATHETER. THE SUBSTANCE WAS 2-3MM BLACK "CHUNKS" THAT FELL TO THE FLOOR WHEN THE PACKAGE WAS OPENED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DEVICE PACKAGING. THE PACKAGE WAS OUT OF BOX HANGING IN A SUPPLY HALLWAY. THE CATHETER WAS REPLACED WITH ANOTHER REPROCESSED STERILMED SOUNDSTAR CATHETER AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507716 N/A REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. 2244101 10888551045094

    Patients

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