BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONO RETRIEVAL DEVICE

    MDR report key: 23503860 · Received November 7, 2025

    Report

    Report Number
    3023548693-2025-00001
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ONOCOR LLC
    Product Code
    MMX
    PMA / PMN Number
    K212988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE LOT. IN PROCESS TENSILE TESTING AT THE BASKET TO SHAFT BOND EXCEEDED THE DESIGN SPECIFICATION OF 17.5 LBF FOR ALL SAMPLES. DEVICES FROM THE SAME LOT WERE INSPECTED AND TENSILE TESTED, NO OBSERVATIONS WERE NOTED AND ALL SAMPLES EXCEEDED THE TENSILE STRENGTH SPECIFICATION. THE FAILURE HAS BEEN UNABLE TO BE REPLICATED.

    Description of Event or Problem · 0

    A PATIENT HAD AN EMBOLIZED BSC WATCHMAN (LEFT ATRIAL APPENDAGE OCCLUDER) DEVICE AND THE ONO RETRIEVAL DEVICE WAS DEPLOYED TO RETRIEVE AND REMOVE IT. THE ONO BASKET BROKE OFF FORM THE TIP OF THE ONO CATHETER. THE ONO BASKET WAS SNARED AND REMOVED WITHOUT INJURY TO THE PATIENT THROUGH THE SHEATH. MULTIPLE ATTEMPTS TO DISCUSS WITH THE PHYSICIAN HAVE BEEN UNANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861283 ONO RETRIEVAL DEVICE PERCUTANEOUS RETRIEVAL DEVICE MMX ONOCOR LLC ONO12-100 230004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown