BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNWAY CLS4 6F

    MDR report key: 10282822 · Received July 15, 2020

    Report

    Report Number
    MW5095549
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATHETER BROKE OFF WHILE IN PATIENT DURING PROCEDURE. HUB OF CATHETER BROKE AND CATHETER HAD SIGNIFICANT KINKS. CATHETER WAS UNABLE TO BE RETRIEVED IN CARDIOVASCULAR LAB. PT TRANSFERRED TO HOSPITAL WITH VASCULAR SURGERY CAPABILITIES. FEMORAL ARTERY CUTDOWN AND CATHETER RETRIEVAL COMPLETED WITHOUT FURTHER INCIDENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738701 RUNWAY CLS4 6F CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 08714729478393 60225922

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention