BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 2903584 · Received December 31, 2012

    Report

    Report Number
    1820334-2013-00016
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PER COMPLAINT FORM: AFTER DIFFICULTY ACCESSING THE RFA DUE TO SEVERE SCAR TISSUE. THE OUTER SHEATH BROKE OFF IN HALF AND A CUTDOWN HAD TO BE PERFORMED IN ORDER TO RETRIEVE THE DISTAL PART OF MPIS SHEATH FROM CFA. (1820334-2013-00016) THEN THEY USED ANOTHER MPIS SET AND THIS TIME THE HUB BROKE OFF FROM THE OUTER SHEATH. SAME DEVICE AND SAME LOT NUMBER. THIS TIME IT DID NOT REQUIRE RETRIEVAL AND EVERYTHING BUT THE WIRE WAS REMOVED TO PLACE A 6FR SHEATH AND CONTINUE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA 3334453

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention