BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 2971206 · Received February 6, 2013

    Report

    Report Number
    1820334-2013-00063
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 10, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME - MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; CATALOG # MPIS-501-10.0-SC-SST. 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. ADDITIONAL COMMENTS: PER THE ATTACHED CAUTION LABEL WE ILLUSTRATE: "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 A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NOTHING IN THE EVENT DESCRIPTION SUGGESTS A POSSIBLE CAUSE. IN PREVIOUS COMPLAINTS WE HAVE FOUND POSSIBLE CAUSES TO INCLUDE DAMAGE TO THE WIRE GUIDE ASSOCIATED WITH WITHDRAWAL THROUGH THE NEEDLE (PER WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. IN THE ABSENCE OF ADDITIONAL INFORMATION A ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT, NO ACTION IS NECESSARY AT THIS TIME AS THERE IS INSUFFICIENT RISK. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: BRAND NAME: MICROPUNCTURE INTRODUCER SET.

    Description of Event or Problem · 1

    WHILE DOING A THORACENTESIS, THE PHYSICIAN REMOVED GUIDEWIRE. THE GUIDEWIRE KINKED AND BROKE OFF INSIDE THE PT. THE PORTION WAS REMOVED UNDER FLUOROSCOPY. NO HARM TO PT AND DOING WELL. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE TO ASSIST IN THIS INVESTIGATION. AS OF (B)(6) 2013, THE DEVICE HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: THE PT WAS UNDERGOING A RIGHT SIDED DIAGNOSTIC THORACENTESIS WHEN THE GUIDEWIRE KINKED AND WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE IT BROKE OFF. A SMALL RESIDUAL COMPONENT WAS LOGGED IN THE RIGHT CHEST WALL AND PLEURAL SPACE. THE PT WAS PLACED UNDER FLUOROSCOPY AND THE RIGHT CHEST WAS EXCISED AND THE RETAINED GUIDEWIRE FRAGMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51478 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. G48006 3659860

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention