BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISISHEATH DILATOR SHEATH TIGHTRAIL

    MDR report key: 23533188 · Received November 12, 2025

    Report

    Report Number
    MW5178763
    Event Type
    Other
    Date Received
    November 12, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 7, 2025
    Manufacturer
    SPECTRANETICS / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    DRE
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TIGHT RAIL USED FOR BLUNT DISSECTION. UNABLE TO REMOVE TIGHT RAIL FROM THE LEAD. DEVICE HAD TO BE DISASSEMBLED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141181 VISISHEATH DILATOR SHEATH TIGHTRAIL DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE SPECTRANETICS / PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV 0303529755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown