BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC. THROMBOLYTIC DEVICE KIT

    MDR report key: 3101398 · Received May 3, 2013

    Report

    Report Number
    2242445-2013-00042
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO. (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CARDIOLOGY, THE PHYSICIAN NOTED THAT PRIOR TO INSERTION NO ISSUES WERE FOUND. AFTER FLUSHING, HE INSERTED THE PTD CATHETER INTO THE PATIENT THEN STARTED THE PROCEDURE. SUDDENLY, THE MIDDLE OF THE CATHETER BROKE AND THE PTD HAS TO BE REMOVED FROM THE PATIENT. NO SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER. THE PHYSICIAN DREW IT BACK IN THE OPPOSITE DIRECTION OF INSERTION. THE PHYSICIAN COMPLAINED THAT IT WAS VERY DIFFICULT TO REMOVE AND AS A RESULT, DAMAGE TO THE VESSEL OCCURRED. A NEW KIT WAS OPENED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY, DEATH, BUT COMPLICATIONS TO THE PATIENT IE VESSEL DAMAGE OCCURRED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194747 PERC. THROMBOLYTIC DEVICE KIT PTD PRODUCTS DXE ARROW INTL., INC. MF2080254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK