BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMICATH PICC

    MDR report key: 4871343 · Received June 25, 2015

    Report

    Report Number
    2245270-2015-00057
    Event Type
    Death
    Date Received
    June 25, 2015
    Date of Event
    April 17, 2015
    Report Date
    June 25, 2015
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS NOT CONFIRMED. HAVING EXAMINED THE PROXIMAL FRAGMENT OF THE THIRD FAULTY SAMPLE RETURNED, WE FOUND THAT THE CATHETER WAS FRAGMENTED AT 10, 2 CM. MICROSCOPIC INSPECTION SHOWED THAT THE CATHETER WAS CUT IN A V-LIKE SHAPE. SUCH DAMAGE IS TYPICAL IF THE CATHETER HAS BEEN PULLED BACK THROUGH THE 24 G PEELABLE NEEDLE. THE PHYSICIAN ADMITTED THAT SHE PROBABLY PULLED THE CATHETER BACK THROUGH THE NEEDLE AFTER THE STOP AT 10 CM. UNFORTUNATELY THE USER DID NOT FOLLOW THIS WARNING. FIRST COMPLAINT FOR THIS BATCH, NO SIMILAR COMPLAINT RECEIVED WITHIN THE LAST 3 YEARS FOR THIS CODE. NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    THEY PLACED A PREMICATH CATHETER IN THE PT'S ARM UNTIL 10 CM WERE IN PLACE, WHEN THE CATHETER STOPPED. THEY TRIED TO REMOVE THE STYLET, WHICH FAILED. UPON THE ATTEMPT TO WITHDRAW THE CATHETER THE CATHETER RUPTURED AND A 10 CM FRAGMENT REMAINED IN THE PT'S ARM AS ULTRASOUND AND X-RAY SHOWED. IT FINALLY MOVED INTO THE RIGHT ATRIUM. THE REST OF THE CATHETER WAS REMOVED FORM THE PT AND RETURNED TO VYGON (B)(4). THE PHYSICIAN ADMITTED THAT SHE PROBABLY PULLED THE CATHETER BACK THROUGH THE NEEDLE AFTER THE STOP AT 10 CM. THE PT WAS MOVED BY HELICOPTER TO ANOTHER HOSPITAL TO REMOVE THE CATHETER WHICH FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411772 PREMICATH PICC LONG TERM INTRAVACULAR CATHETER LJS VYGON GMBH 1261.203 211014GH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death