BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SET:

    MDR report key: 1133069 · Received August 22, 2008

    Report

    Report Number
    9680794-2008-00011
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 22, 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
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTION SITE WAS THE FEMORAL ARTERY PUNCTURE. THE SHEATH/DILATOR WERE INSERTED. UPON REMOVAL OF THE DILATOR, BLOOD STARTED PUMPING THROUGH THE SHEATH. AS A RESULT, A NEW SHEATH AND DILATOR WERE USED WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT. THE DIFFICULTY OCCURRED PRIOR TO INSERTION OF A CATHETER THROUGH THE SHEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK