BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-CATH PRESSURE CATHETER

    MDR report key: 5975010 · Received September 23, 2016

    Report

    Report Number
    1625382-2016-00001
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 19, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MILLAR INC.
    Product Code
    DXO
    PMA / PMN Number
    K093111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP CALL WITH THE DOCTOR WAS DONE. THE DOCTOR INFORMED MILLAR OF THE FOLLOWING. DR. (B)(6) CALLED TO INFORM A CHEST X-RAY WAS PERFORMED ON THE PATIENT AND 5MM OF THE REMAINING CATHETER WAS LOCATED BY THE PATIENT'S FASCIA NEAR THE LVAD. THE TIP APPEARS TO BE 4CM DEEP IN THE SKIN. THE PATIENT HAS REQUESTED NOT TO INTERVENE TO REMOVE THE PORTION OF REMAINING CATHETER. MILLAR IS UNABLE TO PERFORM AN EVALUATION ON THE CATHETER BECAUSE IT WILL NOT BE RETURNED. THE CATHETER WAS DISCARDED AFTER THE PROCEDURE, ACCORDING TO THE DOCTOR. MILLAR DID PERFORM A REVIEW OF THE DEVICE HISTORY RECORDS, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH THE MIKRO-CATH SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. DEVICE NOT RETURNED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    THE MIKRO-CATH WAS PLACED IN THE LEFT ATRIUM OF THE PATIENT DURING O.R PLACEMENT OF A LEFT VENTRICULAR ASSIST DEVICE LVAD. THE MIKRO-CATH WAS PASSED THROUGH THE CHEST WALL USING A PEEL-AWAY LONG NEEDLE CATHETER AND PLACED IN THE LEFT ATRIUM VIA ACCESS THROUGH THE RIGHT SUPERIOR PULMONARY VEIN. USING STERILE TECHNIQUE, THE CATHETER WAS PULLED FROM THE CHEST. DURING THE REMOVAL OF THE CATHETER, THE TIP BROKE OFF SOMEWHERE IN THE SKIN/SOFT TISSUE, AS REPORTED BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626712 MIKRO-CATH PRESSURE CATHETER MIKRO-CATH DXO MILLAR INC. 825-0101

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR