BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 3853484 · Received May 28, 2014

    Report

    Report Number
    1820334-2014-00228
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, A REVIEW A COMPLAINT HISTORY, REVIEW OF QC, AND A REVIEW OF TRENDS WAS CONDUCTED DURING THE INVESTIGATION OF THIS EVENT. PER QUALITY CONTROL SPECIFICATION, THE TYPE AND OUTSIDE DIAMETER OF THE TUBING AND THE SURFACE OF THE CATHETER IS CONFIRMED TO BE SMOOTH, CLEAN, AND FREE OF EXCESSIVE KINKS AND FOREIGN DEBRIS. QUALITY CONTROL PERSONNEL AND CONFIRMS THE SURFACE IS CLEAN AND FREE OF IMPERFECTIONS AND VERIFICATION TESTING EVALUATES THE HUB TO SHAFT BOND. WITHOUT RETURN OF THE COMPLAIN DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. PER THE CONCLUSION OF QUALITY ENGINEERING RISK ASSESSMENT NO RISK MITIGATION ACTION IS NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    DURING A SUPERIOR FEMORAL ARTERY INTERVENTION PROCEDURE, THE SHEATH IN THE MICROPUNCTURE TRADITIONLESS STIFFENED CANNULA ACCESS SET BROKEN OFF INSIDE THE PATIENT'S GROIN AREA. THE PHYSICIAN WAS ABLE TO REMOVE THE FRACTURED PORTION OF THE SHEATH WITH A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313045 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC NA 4858947

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention