BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 2221603 · Received August 19, 2011

    Report

    Report Number
    1820334-2011-00460
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT - UNK AS NOT PROVIDED BY REPORTER. EXP - UNK AS LOT IS UNK. (B)(4). 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 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, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPEC. THE EVENT DESCRIPTION POINTS TO THE PT'S WEIGHT AS A POSSIBLE CONTRIBUTING FACTOR. UNFORTUNATELY SUFFICIENT INFO IS NOT AVAILABLE TO MAKE A CONCLUSIVE ROOT CAUSE ANALYSIS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTIONS ARE REQUIRED PER QERA.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED ACCESS USING MICROPUNCTURE. HE HAD DIFFICULTY DURING THE ACCESS DUE IN PART TO THE WEIGHT OF THE PT. HE ATTEMPTED TO WITHDRAW THE WIRE AND THE PLATINUM TIP SEPARATED FROM THE NITINOL WIRE. UNDER FLUORO THE TIP COULD BE SEEN OUTSIDE OF THE VESSEL BUT IT REMAINED IN FATTY TISSUE DESPITE ATTEMPTS TO RETRIEVE IT WITH FORCEPS. THE PHYSICIAN REPORTS PT WAS UNDER NO DANGER DURING THE PROCEDURE OR FOLLOWING THE PROCEDURE. THE PLATINUM TIP OF THE WIRE REMAINS IN FATTY TISSUE AND OUTSIDE THE ARTERIAL VESSEL. ATTEMPTS AT RETRIEVAL WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other