BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 2243387 · Received August 25, 2011

    Report

    Report Number
    1820334-2011-00487
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 9, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF FOREIGN BODY IS NOT LABELED. SEPARATES NOT SPECIFICALLY LISTED. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. IN ADDITION, EACH PMG WIRE GUIDE COMES WITH AN ATTACHED CAUTION LABEL WHICH ILLUSTRATES; "WITHDRAWAL 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 CONCLUSIVE 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 OR OTHER INSTRUMENT. LESS FREQUENTLY, PATIENT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. THERE IS NOTHING IN THE EVENT DESCRIPTION OR DESCRIPTION OF PATIENT ANATOMY THAT WOULD AID IN THIS COMPLAINT DETERMINATION. THIS COMPLAINT WILL BE LISTED AS INCONCLUSIVE ROOT CAUSE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED TO THE MANUFACTURER ON (B)(6) 2011 THAT A MICROPUNCTURE 0.018 WIRE WAS USED DURING THE HEART CATHERIZATION. POST PROCEDURE, THE PHYSICIAN WAS NOTED THAT VISUALLY THE WIRE APPEARED SHORTER. THE CONCERN WAS THAT THE TIP BROKE OFF AND WAS RETAINED. USING CINEANGIOGRAM, THE TIP OF THE WIRE WAS NOTED IN THE PROFUNDA FEMORIS. THE PHYSICIAN WAS ABLE TO SNARE THE PIECE AND REMOVE IT WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2759572

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R