BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 2002523 · Received January 28, 2011

    Report

    Report Number
    2242445-2011-00011
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) WAS BEING USED ON A MALE PATIENT IN THE CATH LAB. THE PATIENT HAD AN ARTERIOVENOUS (AV) FISTULA IN HIS UPPER ARM THAT WAS CLOTTED ON (B)(6) 2011, AND UNABLE TO COMPLETE DIALYSIS. THE PHYSICIAN ATTEMPTED THREE PASSES WITH THE PTD WHEN THE ORANGE INNER LUMEN BECAME SEPARATED. AS A RESULT, THE SMALL ORANGE INNER LUMEN PIECE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DETERMINED THE CLOT WAS "TOO ORGANIZED" TO RESTORE FLOW AND PLACED A HEMOSPLIT CATHETER IN THE PATIENT. THERE WAS NO DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, FROM THE SALES REPRESENTATIVE STATED THE ORANGE PIECE APPARENTLY CAME OUT WHEN THE BASKET WAS REMOVED FROM THE PATIENT BETWEEN PASSES. THE PHYSICIAN'S ASSISTANT (PA) REMOVED THE ORANGE PIECE WITH HIS HAND AND PLACED IT ON THE TABLE. THE PATIENT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTL., INC. MF0053122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BARD HEMOSPLIT CATHETER