BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS EMBOLECTOMY CATHE TER COMPONENT

    MDR report key: 2201430 · Received August 3, 2011

    Report

    Report Number
    9680794-2011-00054
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K902327
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER WAS PRE-TESTED PRIOR TO INSERTION WITHOUT INCIDENT. THE CATHETER WAS INSERTED AND DURING THE FIRST PASS THE BALLOON RUPTURED WHEN THE CATHETER WAS GOING FROM THE ARTERY INTO THE ANASTOMOSIS. AS A RESULT, THE CATHETER WAS REMOVED AND ANOTHER KIT WAS IMMEDIATELY OPENED AND USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS EMBOLECTOMY CATHE TER COMPONENT WALRUS PRODUCTS DXE ARROW INTERNATIONAL INC CF1046272

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR