BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSRADIAL ACCESS TRAY

    MDR report key: 2852171 · Received November 12, 2012

    Report

    Report Number
    1036844-2012-00318
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD¿L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PATIENT WHILE IN THE CATH LAB. RELEVANT MEDICAL HISTORY/DIAGNOSIS/MEDICATIONS/INDICATIONS FOR USE. TRANSRADIAL ACCESS FOR DIAGNOSTIC CATH PROCEDURE. THE MD ATTEMPTED TO GET ARTERIAL ACCESS WITH THE ARROW 1 INTRODUCER NEEDLE INTO THE PT¿S RIGHT WRIST (TRANSRADIAL ACCESS). THE MD STUCK THE PT NUMEROUS TIMES WITHOUT GETTING ¿FLASHBACK¿ TO INDICATE CORRECT POSITION AND HAD THE NEEDLE FLUSHED A FEW TIMES. AFTER MANY MORE ATTEMPTS, THEY FLUSHED THE NEEDLE ONE MORE TIME AND NOTICED THAT THE FLOW OF THE SALINE WAS NOT AS THEY WOULD EXPECT; IT APPEARED IMPEDED. AS A RESULT, THEY SWITCHED TO A NEW NEEDLE AND AFTER SEVERAL ATTEMPTS GOT ACCESS. THE NEW ARROW NEEDLE HAD BETTER FLOW. IT IS UNCLEAR AT WHAT POINT THE NEEDLE WAS COMPROMISED, ALTHOUGH THE CATH LAB STAFF SAID IT DID NOT APPEAR IMPEDED PRIOR TO USE. THE MD SAID THE PT WAS HEAVILY CALCIFIED AND HAD TORTUOUS ANATOMY. THERE WAS A DELAY OR INTERRUPTION IN THERAPY NOTED WITH NO HARM TO THE PT. THERE WAS NO REPORT OF PATIENT DEATH OR INJURY. THE PT OUTCOME IS THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSRADIAL ACCESS TRAY RADIAL ARTERY PRODUCTS DYB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK