BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS TRAY

    MDR report key: 3062895 · Received April 12, 2013

    Report

    Report Number
    1036844-2013-00152
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 PT. THE INSERTION OCCURRED IN THE CATH LAB AND THE INSERTION SITE WAS THE PT'S TRANSRADIAL ARTERY. THE INSERTION STARTED AS NORMAL. THE INTRODUCER NEEDLE PLACED AS NORMAL, THEN AFTER SHEATH PLACED IN THE ARTERY, PROBLEM WAS WITH THE REMOVAL OF THE SPRING WIRE GUIDE (SWG) AND DILATOR. THERE WAS RESISTANCE FROM THE SWG WHICH SEEMED TO HAVE STARTED TO UNCOIL. THE SWG AND DILATOR WERE REMOVED, BUT THERE SEEMED TO BE APPROXIMATELY 2CM OF THE SWG LEFT IN THE PT'S ARTERY. THE VASCULAR SURGEON WILL ASSESS AS SOON AS POSSIBLE AND THE OUTCOME WILL BE CONFIRMED AFTER THAT. POSSIBLE INTERVENTION REQUIRED TO REMOVE THE EXCESS SWG, BUT TO BE CONFIRMED. ACCORDING TO THE REPORT SUBMITTED TO THE (B)(6) BY THE HEAD OF PT SAFETY AND RISK: CORONARY ANGIOGRAM VIA RADIAL ARTERY PROCEDURE. "ON REMOVAL OF GUIDE WIRE FROM RADIAL ACCESS KIT, WIRE APPEARED FRAYED AND UNRAVELED. SMALL FRAGMENT OF THIS WIRE LEFT IN RADIAL ARTERY. NOT ABLE TO REMOVE WIRE FRAGMENT INITIALLY ON SHEATH REMOVAL AS PRESSURE APPLIED FROM A TR BAND. FRAGMENT REMAINS IN PT. DEVICE SAVED. REMAINING DEVICES WITH THE SAME LOT NUMBER REMOVED FOR USE. DOCTOR ATTEMPTED TO REMOVE WIRE FRAGMENT UNSUCCESSFULLY. THE MD CONTACTED THE SALES REP. MD TO DISCUSS WITH VASCULAR SURGEONS TOMORROW ((B)(6) 2013). PT WELL AND ALLOWED TO GO HOME." ADD'L INFO REC'D ON (B)(4) 2013 STATING THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159091 ACCESS TRAY ARTERIAL CATHETER PRODUCTS KGZ ARROW INTL., INC. RF2072114

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other