BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE CAMP SHEATH SYSTEM

    MDR report key: 21848911 · Received April 16, 2025

    Report

    Report Number
    3016522967-2025-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K191717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PRODUCT MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO QUALITY ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    DOCTOR COULD NOT ADVANCE AN 035" GUIDEWIRE THROUGH BASE CAMP SELECT CATHETER. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104340 BASE CAMP SHEATH SYSTEM PERCUTANEOUS CATHETER DQY ROUTE 92 MEDICAL, INC. 24112701

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Other BASE CAMP SHEATH SYSTEM