BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 22609094 · Received July 25, 2025

    Report

    Report Number
    2134070-2025-00011
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 7, 2025
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551045216
    PMA / PMN Number
    K180890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND WHEN IT WAS TAKEN OUT OF THE PACKAGE, THE TIP WAS CRACKED AND HANGING. A NON-STERILE REPROCESSED VIEWFLEX¿ XTRA ICE CATHETER 9FR, WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. NONE OF THE ORIGINAL PACKAGING WAS RETURNED FOR EVALUATION. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS CONDUCTED. THE DISTAL TIP OF THE CATHETER IS OBSERVED TO BE FRACTURED AND BENT, BUT STILL IN ONE PIECE. NO OTHER ADDITIONAL DAMAGE IS OBSERVED. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME, UNDER LOT 2230251, SERIAL NUMBER (B)(6). THE ISSUE REPORTED REGARDING A BROKEN TIP IS CONFIRMED BASED ON THE FINDINGS MENTIONED ABOVE. WITH THE LIMITED INFORMATION PROVIDED, AND NONE OF THE ORIGINAL PACKAGE RETURNED, THERE IS NO CLEAR INSIGHT INTO THE ROOT CAUSE AND/OR EXACT CONTRIBUTING FACTORS THAT MAY HAVE RESULTED IN THE OBSERVED FAILURE MODE. THE CAUSE OF THIS ISSUE, OR WHEN IT OCCURRED (DURING TRANSIT DELIVERY, AS WELL AS REMOVAL AND SUBSEQUENT HANDLING FROM ITS PACKAGING), IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 2230251 (MANUFACTURING DATE 05/15/2025) WAS CONDUCTED, AND NO MANUFACTURING DISCREPANCIES WERE IDENTIFIED. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGE FROM LEAVING THE FACILITY. THIS ISSUE IS BEING FURTHER ADDRESSED THROUGH STERILMED¿S QUALITY SYSTEM AND ACTIONS ARE BEING TAKEN ON THE SUPPLIER¿S SIDE. 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 PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND WHEN IT WAS TAKEN OUT OF THE PACKAGE, THE TIP WAS CRACKED AND HANGING. THERE WAS NO PATIENT INJURY OR CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23342 NA DIAGNOSTIC INTRAVASCULAR CATHETER OWQ STERILMED, INC. 2230251 10888551045216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown