BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 2002521 · Received January 28, 2011

    Report

    Report Number
    2242445-2011-00013
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 THIS EVENT INVOLVED A PATIENT THAT HAD AN 8.5 PERCUTANEOUS SHEATH INTRODUCER (PSI) WITH SHEATH ADAPTER (SA-09847) AND A 5FR BIPOLAR BALLOON ELECTRODE CATHETER INSERTED IN THE EMERGENCY ROOM AT 07:10. THE PATIENT ARRIVED FROM EMERGENCY DEPARTMENT TO THE CRITICAL CARE UNIT WITH THE CATH-GARD FILLED WITH SEROSANG FLUID. AT 9:00, THE EDUCATOR ATTEMPTED TO TIGHTEN THE TUOHY-BORST ADAPTER AND WAS UNABLE. AT 12:00, THE FELLOW DISCONTINUED THE BIPOLAR ELECTRODE AND APPLIED THE OBTURATOR CAP TO THE PSI. AS A RESULT, THE PSI WAS COMPLETELY REMOVED FROM THE PATIENT ON (B)(6) 2011. THE PATIENT OUTCOME IS "CONDITION IS STABLE." THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN