BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 4102422 · Received August 27, 2014

    Report

    Report Number
    9680794-2014-00147
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ARROW INTERNACIONAL INC.
    Product Code
    MCW
    PMA / PMN Number
    K990829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF BUT DID NOT SEPARATE. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT DEATH REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519118 PERCUTANEOUS THROMBOLYTIC DEVICE KIT PTD PRODUCTS MCW ARROW INTERNACIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1