BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS EMBOLECTOMY CATHETER COMPONENT

    MDR report key: 3202101 · Received June 27, 2013

    Report

    Report Number
    9680794-2013-00033
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K902327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT DEFLATE. THE BALLOON TOOK SEVERAL DIFFERENT ATTEMPTS TO DEFLATE. EVENTUALLY THE BALLOON WAS SLOWLY DEFLATED AND REMOVED FROM THE SHEATH. THE EVENT OCCURRED IN THE SURGERY DEPARTMENT AND THE CATHETER WAS BEING PLACED IN THE RIGHT ARM FISTULA OF A MALE PT. A NEW BALLOON CATHETER WAS OPENED AND USED SUCCESSFULLY. IT IS UNK IF THERE WAS A DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293669 WALRUS EMBOLECTOMY CATHETER COMPONENT WALRUS PRODUCTS DXE ARROW INTERNATIONAL INC CF3028496

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK