BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP COIL SYSTEM

    MDR report key: 17423740 · Received July 31, 2023

    Report

    Report Number
    17423740
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    May 27, 2023
    Report Date
    July 6, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    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

    THE COIL COULD NOT BE REMOVED FROM THE SLEEVE AND IMPLANTED INTO THE PATIENT. THE COIL WAS REMOVED AND REPLACED WITHOUT INCIDENT OR HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR RUBY LP COIL 1MM X 2 MM, RUBY LP COIL 1MM X 2 MM (PER SITE REPORTER), UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605376 LP COIL SYSTEM DEVICE, NEUROVASCULAR EMBOLIZATION HCG PENUMBRA, INC. RBYLP0102 F113166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown