BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDING SHEATH SLENDER R2P 6FR

    MDR report key: 25112749 · Received May 7, 2026

    Report

    Report Number
    MW5187860
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 4, 2026
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE PROCESS OF REMOVING THE R2P-RADIAL-TO-PERIPHERAL SLENDER SHEATH FROM THE RIGHT RADIAL ARTERY WHEN THE ARTERY STARTED SPASMING, EVEN AFTER ADDITIONAL RADIAL COCKTAILS (VERAPAMIL AND NTG-NITROGLYCERIN) WERE GIVEN. THE SHEATH BROKE OFF FROM THE HUB. THE RIGHT FEMORAL ARTERY WAS THEN ACCESSED, AND A SNARE WAS USED TO RETRIEVE THE REMAINING SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525341 GUIDING SHEATH SLENDER R2P 6FR INTRODUCER, CATHETER DYB TERUMO MEDICAL CORP. GS-R6ST1C75W 0001455278

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention