BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRESS DIAGNOSTIC PERIPHERAL CATHETER

    MDR report key: 3241099 · Received July 18, 2013

    Report

    Report Number
    1628221-2013-00017
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K053171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED AS THE USER DID NOT PROVIDE A LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE CATHETER HAD SEPARATED FROM THE CATHETER BODY TUBING AT THE FUSE ZONE. IT WAS OBSERVED THAT THE TIP WAS SIGNIFICANTLY DEFORMED DIRECTLY DISTAL TO WHERE IT BROKE FROM THE CATHETER. THE AREA WHERE THE TIP SEPARATED ALSO APPEARED VERY JAGGED, INDICATING THAT THE CATHETER TIP HAD BEEN TORN AWAY FROM THE DEVICE UNDER EXCESSIVE FORCE. TWO KINKS WERE ALSO FOUND IN THE BODY OF THE CATHETER. THE FUSE ZONE WAS EXAMINED UNDER MAGNIFICATION. IT APPEARED THAT THE CATHETER TIP HAD BEEN WELL BONDED TO THE CATHETER BODY PRIOR TO THE EVENT. THE CONDITION OF THE RETURNED DEVICE INDICATES THAT EXCESSIVE FORCE WAS APPLIED TO THE CATHETER DURING THE PROCEDURE. HOWEVER, MERIT IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE FO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AT THE END OF A FISTULA GRAM PROCEDURE THE BLACK TIP OF THE CATHETER DETACHED WHILE THE CATHETER WAS BEING REMOVED FROM THE PT THROUGH A 6F OR 7F SHORT SHEATH INTRODUCER. THE USER REPORTED THAT THE PHYSICIAN INITIALLY FELT RESISTANCE WHILE ATTEMPTING TO REMOVE THE CATHETER. WHEN THE CATHETER WAS REMOVED FROM THE PT THE PHYSICIAN NOTICED THAT THE TIP OF THE CATHETER WAS MISSING. THE TIP WAS FOUND STICKING OUT OF THE SHEATH INTRODUCER STILL ON THE GUIDE WIRE. THE PHYSICIAN WAS ABLE TO PULL THE DETACHED TIP OUT OF THE PT WITH THE SHEATH INTRODUCER AND GUIDE WIRE IN ITS ENTIRETY. THIS WAS CONFIRMED WITH FLUOROSCOPIC VISUALIZATION. NO HARM OR INJURY WAS REPORTED. THE USER DID NOT PROVIDE A LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336376 IMPRESS DIAGNOSTIC PERIPHERAL CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 PRELUDE SHORT SHEATH INTRODUCER| GUIDE WIRE