BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SE T:

    MDR report key: 2013793 · Received February 4, 2011

    Report

    Report Number
    9680794-2011-00008
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 3, 2011
    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

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY INTERVENTIONAL RADIOLOGY THAT THE MD USED THE DILATOR FOLLOWING THE INSTRUCTIONS FOR USE. THE CONNECTION PART BETWEEN THE DILATOR TUBING (LIGHT BLUE COLOR) AND THE HUB (BLACK COLOR) BROKE DURING THE PROCEDURE. THE KIT WAS REPLACED WITH A NEW ONE CAUSING A 5 MINUTE DELAY IN THERAPY. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS NOTED. THERE WAS NO HARMFUL OUTCOME TO THE PT.

    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 CF8013668

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK