BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURVEIL DCB

    MDR report key: 23595544 · Received November 19, 2025

    Report

    Report Number
    3001374820-2025-00002
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 19, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    ONU
    UDI-DI
    00812339030388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED COMPLETE RADIAL TEAR ON PROXIMAL END. THE INVESTIGATION COULD NOT CONFIRM WHETHER THE BALLOON TEAR WAS CAUSED BY THE CLOSURE DEVICE OR BALLOON BURST.

    Description of Event or Problem · 0

    A 4.0MM X 150MM X 135CM SURVEIL DRUG-COATED BALLOON (LOT W240003) WAS USED TO TREAT A LESION IN THE COMMON FEMORAL ARTERY OF A 58-YEAR-OLD FEMALE PATIENT WITH A RELEVANT HISTORY OF DIALYSIS, HYPERTENSION, PERIPHERAL ARTERY DISEASE, CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, AND DIABETES. DURING THE PROCEDURE, A NON-ABBOTT CLOSURE DEVICE WAS PRESENT PROXIMALLY IN THE ANATOMY. THE SURVEIL BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED AS INTENDED. UPON INFLATION, A LOSS OF PRESSURE WAS NOTED AND BALLOON RUPTURE WAS SUSPECTED. THERE WAS RESISTANCE ENCOUNTERED WITH THE CLOSURE DEVICE DURING REMOVAL; THE BALLOON WAS PULLED AWAY FROM THE DEVICE BUT DID NOT DETACH, AND THE ENTIRE DEVICE WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THE PROCEDURE WAS COMPLETED AT THAT POINT. NO ADDITIONAL CLINICAL CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310077 SURVEIL DCB Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU SURMODICS, INC. SRV03513504015 W240003 00812339030388

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female