BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI KIT: 6FR

    MDR report key: 4101715 · Received August 28, 2014

    Report

    Report Number
    1036844-2014-00361
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FEMALE PATIENT WAS BROUGHT INTO THE E.R. AS A MOTOR VEHICLE ACCIDENT VICTIM WITH A RUPTURED SPLEEN. A 6FR PSI AK-09601 WAS PLACED WITH A 5FR PACING WIRE. THIS WAS A RIGHT SIDE FAILURE AND THE PATIENT WAS BLEEDING OUT. THERE WAS NO BLOOD SEEN IN THE CONTAMINATION SHIELD. THE PHYSICIAN FEELS THAT THE SHEATH DID JOT SEAL SUFFICIENTLY AND THE PATIENT RECEIVED AN AIR EMBOLISM WHICH RESULTED IN HER BEING INTUBATED. SHE WAS INITIALLY REPORTED AS CRITICAL, HOWEVER, THE PATIENT IS REPORTED TO BE RECOVERING AND IS STABLE. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH REPORTED. TIS WAS BEING USED WITH SA-09847/LOT 23F13H0577.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526244 PSI KIT: 6FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT # 23F13H0577.| ARROW SHEATH ADAPTER, PRODUCT # SA-09847,