BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 24463891 · Received February 26, 2026

    Report

    Report Number
    2134070-2026-00003
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 26, 2026
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551045087
    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

    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).

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED; THEREFORE, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THE DEVICE HISTORY RECORD FOR LOT 2242632 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED SOUNDSTAR® CATHETER AND AFTER THE STAFF OPENED THE PACKAGING, THEY FOUND A STICKER, ABOUT EIGHT INCHES FROM THE TOP ON THE CATHETER, THAT WAS VERY STICKY. THE STICKINESS WAS ALL OVER THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52424 NA CATHETER, ELECTRODE RECORDING OWQ STERILMED, INC. 2242632 10888551045087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown