BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    070 ACCESS SYSTEM (HIPOINT 70)

    MDR report key: 20646619 · Received November 8, 2024

    Report

    Report Number
    3016522967-2024-00005
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ROUTE 92 MEDICAL, INC.
    Product Code
    QJP
    PMA / PMN Number
    K203043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN USED A HIPOINT 70 CATHETER INSIDE OF A KINKED WALRUS BALOON GUIDE CATHETER TO REINFORCE STABILITY AND AVOID LOSING ACCESS. WHEN HE REACHED THE KINKED PORTION HE REPORTED TO HAVE PUSHED AGAINST THE RESISTANCE INSIDE THE KINKED WALRUS CATHETER, CAUSING THE TIP OF THE HIPOINT 70 TO SEPARATE. THE WALRUS CATHETER WAS PULLED OUT WITH THE HIPOINT 70 TIP INSIDE THE CATHETER. NO HARM WAS CAUSED TO THE PATIENT. HIPOINT 70 CATHETER IS NOT COMPATIBLE WITH THE WALRUS BALOON GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815564 070 ACCESS SYSTEM (HIPOINT 70) PERCUTANEOUS CATHETER QJP ROUTE 92 MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 070 ACCESS SYSTEM (HIPOINT 70).| WALRUS BALOON GUIDE CATHETER.