BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 1982701 · Received February 4, 2011

    Report

    Report Number
    1820334-2011-00075
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SEPARATES/BREAKAGE IS ADDRESSED ON THE PROVIDED CAUTION LABEL. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS DURING PROCESSING AND PRIOR TO TRANSPORT. PER THE ATTACHED PROVIDED CAUTION LABEL, IT IS ILLUSTRATED; "WITHDRAW AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." WITHOUT THE COMPLAINT DEVICE WE CANNOT MAKE A DEFINITE ROOT CAUSE ANALYSIS. WHEN WE HAVE SEEN THIS TYPE OF DEVICE FAILURE IN THE PAST IT HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL THROUGH THE NEEDLE (SEE WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PATIENT ANATOMY MAKES WITHDRAW OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. THE STATEMENT IN THE EVENT DESCRIPTION "THE VESSEL WAS TORTUROUS AND THE END OF THE GUIDEWIRE BECAME KNOTTED WHEN ATTEMPTED TO REMOVE AND BROKE OFF" INDICATES THAT PATIENT ANATOMY WAS EITHER THE CAUSE OR SIGNIFICANTLY CONTRIBUTED TO THIS DEVICE FAILURE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AS REPORTED TO COOK VIA MAUDE REPORT: DURING PLACEMENT OF IVC FILTER, THE RIGHT GROIN WAS ACCESSED WITH MICROPUNCTURE. WHILE ATTEMPTING TO PLACE GUIDEWIRE INTO FEMORAL VEIN, THE GUIDEWIRE BECAME TANGLED AROUND ITSELF. FEMORAL VEIN WAS THEN ACCESSED ON OPPOSITE SIDE AND GUIDEWIRE SNARE. CUSTOMER RETURNED CALL ON (B)(6) 2011 WITH THE INFORMATION THAT THE PHYSICIAN WAS PERFORMING A VENOUS ACCESS TO THE RIGHT FEMORAL. THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDEWIRE THROUGH THE NEEDLE. THE VESSEL WAS TORTUROUS AND THE END PF THE GUIDEWIRE BECAME KNOTTED WHEN ATTEMPTED TO REMOVE AND BROKE OFF. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2576768

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention