BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH-LAB SHEATH INTRO SET

    MDR report key: 1132658 · Received August 22, 2008

    Report

    Report Number
    9680794-2008-00013
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FIELD IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE TIP FO THE DILATOR WAS NOT TAPERED WELL MAKING INSERTION DIFFICULT. DURING THE INSERTION PROCESS, THE SHEATH HOOKED ON THE VESSEL CAUSING VESSEL TRAUMA. THERE HAS BEEN A REQUEST FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH-LAB SHEATH INTRO SET INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC CF7050145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK