BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC MICROEZ MICROINTRODUCER 5.0 F WITH VESSEL DILATOR

    MDR report key: 24835316 · Received April 9, 2026

    Report

    Report Number
    MW5186640
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 7, 2026
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POWERPICC PROVENA MICROEZ MICROINTRODUCER SHEATH 5.0 F (1.8 MM ID X 2.5 MM OD X 7 CM LENGTH) WITH VESSEL DILATOR (0.5 MM ID) WAS UNABLE TO THREAD THROUGH INSERTION SITE; TIP OF OUTER CANNULA OF THE SHEATH BUCKLED AND WAS UNABLE TO MAINTAIN THE SHAPE INTEGRITY DURING INSERTION ATTEMPT, REQUIRING STOPPING INSERTION OF SHEATH TO PREVENT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898872 POWERPICC MICROEZ MICROINTRODUCER 5.0 F WITH VESSEL DILATOR CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. REKV2248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention