BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R2P DESTINATION SLENDER

    MDR report key: 23712124 · Received December 3, 2025

    Report

    Report Number
    1118880-2025-00169
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 3, 2025
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701012360
    PMA / PMN Number
    K193125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. BASED ON THE EVALUATION OF THE RETURNED SAMPLE THIS REPORT IS NOW DEEMED NOT REPORTABLE. ONE R2P SHEATH AND PACKAGING WERE RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. THE SHEATH IS FRACTURED 0.6CM FROM THE SHEATH HUB. NO OTHER DAMAGE OR DEFORMITIES WERE NOTED ON THE SHEATH. ONE R2P SHEATH WAS RETURNED FOR ASSESSMENT, AND THE SHEATH IS FRACTURED NEAR THE SHEATH HUB. THE COMPLAINT CAN BE CONFIRMED FOR SHEATH DAMAGE. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CAUSE IS THE SHEATH WAS DAMAGED DURING REMOVAL FROM THE PACKAGING. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES AND THE DEVICE WAS RELEASED IN A CONFORMING STATE. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE HAZARD BASED RISK TABLE (HBRT).

    Additional Manufacturer Narrative · 0

    A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: CLINICAL LEAD. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: IT WAS NOTICED THAT THE DESTINATION SLENDER STARTED TO SEPARATE BELOW THE HUB AFTER PULLING DIRECTLY OUT OF THE PACKAGE. THE PROCEDURE WAS A CARDIAC CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120560 R2P DESTINATION SLENDER INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION GS-R6ST1C75W 0000865912 00389701012360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown