BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 3901859 · Received May 8, 2014

    Report

    Report Number
    3001627457-2014-00009
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    EKOS CORP.
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 40 CM (LOT#-SERIAL#: (B)(4)) AND 50 CM (LOT#-SERIAL#: (B)(4)) DEVICES WERE RETURNED TO EKOS. INSPECTION OF THE 40 CM KIT AND 50 CM KIT FOUND PINCH AND KINK MARKS ON THE WORKING LENGTH CONSISTENT WITH DIFFICULTY IN ADVANCING THE DEVICE. IT WAS CONFIRMED THAT THE 50 CM ULTRASOUND WIRE WAS FRACTURED, WITH ALL COMPONENTS PRESENT ON THE RETURNED FRACTURED DEVICE. THERE WAS NO OTHER EVIDENCE OF DAMAGE OR ABNORMALITY. REVIEW OF THE MANUFACTURING RECORDS FOUND NO UNUSUAL PROCESSING PROCEDURES AND THE DEVICE PASSED ALL INSPECTIONS. THE CONDITION OF THE DEVICES WAS CONSISTENT WITH THE REPORTED EVENT WHERE THE DEVICE WAS DIFFICULT TO ADVANCE. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO CONTINUE USING THE DEVICE IF IT BECOMES KINKED. F/U INFO INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    TWO EKOS DEVICES WERE USED SEQUENTIALLY IN AN ATTEMPT TO PLACE THE DEVICES OVER THE AORTIC ARCH BIFURCATION: THE 40 CM TREATMENT ZONE DRUG INFUSION CATHETER WAS PLACED OVER THE BIFURCATION AND THE ULTRASOUND WIRE WAS THEN INSERTED INTO THE DRUG INFUSION CATHETER. THE ULTRASOUND WIRE COULD NOT BE FULLY INSERTED AND WAS KINKED. BOTH ULTRASOUND WIRE AND DRUG DELIVERY CATHETER WERE REMOVED. A 50 CM TREATMENT ZONE DRUG INFUSION CATHETER WAS SUBSEQUENTLY INSERTED, AND THE ULTRASOUND WIRE WAS INSERTED INTO THE DRUG INFUSION CATHETER. THE PHYSICIAN INDICATED THE ULTRASOUND WIRE ENCOUNTERED STRONG RESISTANCE WHEN TRYING TO ADVANCE VER THE BIFURCATION AND BROKE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE FRACTURED ULTRASOUND WIRE BY REMOVING THE DRUG INFUSION CATHETER. A STANDARD INFUSION CATHETER WAS THEN USED. F/U INFO INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE EKOS DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280142 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORP. 135CM, 50CM 130611024-004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK