BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SE T:

    MDR report key: 1230385 · Received November 7, 2008

    Report

    Report Number
    9680794-2008-00019
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SHEATH WAS PLACED IN THE FEMORAL VEIN DURING AN ANGIOPLASTY PROCEDURE. A GUIDING CATHETER WAS SEATED IN THE SHEATH AND THE PHYSICIAN ATTEMPTED TO INJECT MEDICATION INTO THE SIDE ARM. HOWEVER, WHILE INJECTING THE MEDICATION, THE SIDE ARM BECAME "BLOWN OFF". IT WAS REPORTED THIS OCCURRED A FEW TIMES. THERE IS NO FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH-LAB SHEATH INTRO SE T: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. CF8058920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK