BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-RAILWAY

    MDR report key: 10369602 · Received August 5, 2020

    Report

    Report Number
    9616099-2020-03826
    Event Type
    Injury
    Date Received
    August 5, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 5, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY RAJE V, KRATHEN C, SANGHVI K. EVALUATION OF RAILWAY SHEATHLESS ACCESS SYSTEM FOR TRANSRADIAL CORONARY AND PERIPHERAL INTERVENTIONS [PUBLISHED ONLINE AHEAD OF PRINT, 2020 JUN 15]. CARDIOVASC REVASC MED. 2020;S1553-8389(20)30367-5. DOI:10.1016/J.CARREV.2020.06.016, TWO PATIENTS DEVELOPED RADIAL SPASMS DURING PROCEDURE WITH THE RAILWAY SHEATHLESS ACCESS SYSTEM. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. TREATMENT OF ARTERIAL SPASMS MAY INCLUDE MEDICATIONS SUCH AS NITRATES AND CALCIUM CHANNEL BLOCKERS. THE RAILWAY SHEATHLESS ACCESS SYSTEM SHOULD BE AVOIDED IN VASCULATURE WITH EXTREME TORTUOSITY, CALCIFIED PLAQUE OR THROMBUS. RADIAL ACCESS IS CONTRAINDICATED IN PATIENTS WITH INADEQUATE CIRCULATION TO THE EXTREMITY AS EVIDENCED BY SIGNS OF ARTERY OCCLUSION OR ABSENCE OF RADIAL PULSE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY RAJE V, KRATHEN C, SANGHVI K. EVALUATION OF RAILWAY SHEATHLESS ACCESS SYSTEM FOR TRANSRADIAL CORONARY AND PERIPHERAL INTERVENTIONS [PUBLISHED ONLINE AHEAD OF PRINT, 2020 JUN 15]. CARDIOVASC REVASC MED. 2020;S1553-8389(20)30367-5. DOI:10.1016/J.CARREV.2020.06.016, TWO PATIENTS DEVELOPED RADIAL SPASMS DURING PROCEDURE WITH THE RAILWAY SHEATHLESS ACCESS SYSTEM. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831884 UNK-RAILWAY DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNK-RAILWAY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1