BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIVU ANGIOSCOPE

    MDR report key: 19483789 · Received June 7, 2024

    Report

    Report Number
    19483789
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    February 26, 2024
    Report Date
    April 19, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LYK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER PRODUCT WAS REMOVED FROM THE PACKAGING, IT WAS OBSERVED THAT THERE WAS A KINK IN THE TUBING, NEAR THE BLACK HANDLE, AND THE WIRE INSIDE WAS SEVERED. PRODUCT WAS ATTEMPTED TO BE USED BUT DID NOT FUNCTION PROPERLY. MANUFACTURER RESPONSE FOR PERIVU DISPOSABLE ANGIOSCOPE, PERIVU DISPOSABLE ANGIOSCOPE (PER SITE REPORTER). EMAILED TO [REDACTED NAME] FROM [REDACTED NAME]. [REDACTED DATE] MANUFACTURER COMPLAINT FORM SENT TO [REDACTED NAME].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150333 PERIVU ANGIOSCOPE ANGIOSCOPE LYK LEMAITRE VASCULAR, INC. A5000 ANG1200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown