BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 2103801 · Received May 24, 2011

    Report

    Report Number
    2242445-2011-00065
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A PATIENT IN THE CARDIAC CATH LAB. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 STATED THEY STARTED USING THE PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) 7 FR IN THE PATIENT'S FISTULA LOCATED IN THE RIGHT ARM. AFTER A FEW PASSES, THE TIP OF THE CATHETER BECAME DETACHED. THEY ATTEMPTED TO USE A SNARE TO REMOVE THE TIP, BUT WERE UNSUCCESSFUL. AS A RESULT, THEY PLACED A STENT OVER THE TIP IN THE FISTULA SO IT WOULD NOT TRAVEL. THEY USED ANOTHER PTD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTL., INC. MF0126348

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention