BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSRADIAL ACCESS TRAY

    MDR report key: 2852170 · Received November 12, 2012

    Report

    Report Number
    1036844-2012-00319
    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 INTO THE PT¿S RIGHT WRIST (TRANSRADIAL ACCESS). THE MD FED THE DILATOR AND SHEATH OVER THE SPRING WIRE GUIDE (SWG). WHEN THE MD ATTEMPTED TO GET ACCESS INTO THE PT THE DILATOR WOULD NOT ADVANCE. THE MD THEN MADE A SMALL SKIN NICK AND TRIED AGAIN TO ADVANCE THE DILATOR INTO THE PATIENT. WHEN THE RESISTANCE WAS MET AGAIN THE MD REMOVED THE DILATOR AND SHEATH SUCCESSFULLY. AS A RESULT, THE MD REPLACED THE DILATOR/SHEATH WITH A COMPETITOR¿S DEVICE. UPON INSPECTION, THE DILATOR APPEARED TO BE FLARED AT THE TIP AND SLIGHTLY CRACKED. THE MD THOUGHT IT COULD HAVE CAUGHT ON THE SWG, BUT DOES NOT HAVE RECOLLECTION OF THAT HAPPENING. 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