BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-RAILWAY

    MDR report key: 10382233 · Received August 7, 2020

    Report

    Report Number
    9616099-2020-03835
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 7, 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

    PLEASE NOTE THIS REPORT IS RELATED TO REPORT # 9616099-2020-03826. 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, ONE PATIENT WITH A ¿DOUBLE HAIR PIN¿ RADIAL LOOP DEVELOPED SEVERE SPASM, PAIN, ALONG WITH A RADIAL HEMATOMA AND SUBSEQUENT RADIAL ARTERY OCCLUSION (RAO) DURING USE OF THE RAILWAY SHEATHLESS ACCESS SYSTEM. THE PROCEDURE WAS COMPLETED BY SWITCH OVER TO THE FEMORAL APPROACH. 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. VASCULAR COMPLICATIONS INCLUDING VESSEL SPASM AND OCCLUSION ARE KNOWN POTENTIAL ADVERSE EVENTS 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. ACCESS SITE BLEEDS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. ADEQUATE SHEATH REMOVAL TECHNIQUE AND PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION ARE ROOT CAUSES OF HEMATOMA FORMATION. PAIN IS A WELL-KNOWN POTENTIAL ADVERSE EVENT AND IS DEFINED AS A FEELING TRIGGERED IN THE NERVOUS SYSTEM. PAIN MAY BE SHARP OR DULL AND IT MAY COME AND GO, OR IT MAY BE CONSTANT. THIS COMPLICATION MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AND USERS ARE TRAINED AND EXPERIENCED IN HOW TO TREAT THIS COMMON COMPLICATION. 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, ONE PATIENT WITH A ¿DOUBLE HAIR PIN¿ RADIAL LOOP DEVELOPED SEVERE SPASM, PAIN, ALONG WITH A RADIAL HEMATOMA AND SUBSEQUENT RADIAL ARTERY OCCLUSION (RAO) DURING USE OF THE RAILWAY SHEATHLESS ACCESS SYSTEM. THE PROCEDURE WAS COMPLETED BY SWITCH OVER TO THE FEMORAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845527 UNK-RAILWAY DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNK-RAILWAY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1