BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURVEIL DCB

    MDR report key: 22974349 · Received September 4, 2025

    Report

    Report Number
    3001374820-2025-00001
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 4, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    ONU
    PMA / PMN Number
    P210025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE DRUG COATED BALLOON (DCB) WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE. THE BALLOON WAS INFLATED WITH WATER MEDIA AND A PUNCTURE WAS OBSERVED APPROXIMATELY 9CM FROM THE DISTAL TIP. THE PUNCTURE WAS JAGGED AND WAS TRANSVERSE IN ORIENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SURVEIL DRUG COATED BALLOON (DCB) WAS USED IN A PROCEDURE TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE TO HEAVY CALCIFICATION. THE DCB WAS ADVANCED TO THE TARGET LESION USING THE CROSSOVER METHOD. THE BALLOON WAS INFLATED AND RUPTURED AT THE PRESSURE OF 7ATM. THE ISSUE OCCURRED DURING THE INITIAL INFLATION. THE DCB WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATION. ANOTHER SURVEIL BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT. THE DCB WAS PREPPED PER IFU. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976424 SURVEIL DCB Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU SURMODICS, INC. SRV03513505015 W240008

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male