BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTERIAL CATH SET: 18GA C ATH/20GA NDL

    MDR report key: 1738973 · Received June 25, 2010

    Report

    Report Number
    1036844-2010-00170
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    April 18, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT THAT THE PHYSICIAN WAS ATTEMPTING TO INSERT AN ARTERIAL LINE INTO PT'S FEMORAL ARTERY USING THE FEMORAL ARTERY CATHETER. HE WAS ADJUSTING THE STYLET AND THE TIP BROKE AFTER MULTIPLE ATTEMPTS TO CANNULATE THE FEMORAL ARTERY WERE UNSUCCESSFUL. THERE WAS NO HARM TO THE PT. THE TIP WAS RETRIEVED. HE STATED HE HAS HAD THIS PROBLEM WITH THE SAME PRODUCT PREVIOUSLY. THE PT WAS ADMITTED WITH CARDIAC ARREST AND SHE EVENTUALLY DIED DUE TO THE ORIGINAL EVENTS. ADDITIONAL INFO WAS RECEIVED FROM THE HOSP ON 6/10/2010 WHICH STATED THE PHYSICIAN REPORTED THIS EVENT TO AN RN. THE PHYSICIAN STATED THIS DID NOT CONTRIBUTE TO THE PT'S DEATH. ANOTHER CATHETER WAS NOT USED ON THIS PT. "IT IS UNLIKELY THAT THE ARTERIAL CATHETER WAS A CAUSAL OR CONTRIBUTING FACTOR TO THE DEATH OF THE PT. THE REPORTING HEALTHCARE PROFESSIONAL SAID THE PHYSICIAN MENTIONED IN PASSING THIS HAS HAPPENED PREVIOUSLY, BUT NO REPORT HAS EVER BEEN FILED OR WILL BE FILED. THEY ALSO STATED THE HOSP WILL NOT BE SUBMITTING A REPORT FOR ANOTHER ISSUE. WE ARE SUBMITTING THIS REPORT BECAUSE WE HAVE DETERMINED THAT ON THE INFO AVAILABLE, WE CANNOT CONCLUDE WITH CERTAINTY THAT THE DEVICE WAS NOT A CONTRIBUTING FACTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATH SET: 18GA C ATH/20GA NDL ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. RF9085904

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death