BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 3964121 · Received July 11, 2014

    Report

    Report Number
    1820334-2014-00301
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    March 5, 2014
    Report Date
    June 19, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION. DURING OUR INVESTIGATION, A REVIEW OF COMPLAINT HISTORY, REVIEW OF QC, AND A REVIEW OF TRENDS WAS PERFORMED. PER QUALITY CONTROL SPECIFICATION, THERE IS 100% INSPECTION, CONFIRMING THE INTEGRITY OF THIS DEVICE. AS NO PRODUCT WAS RETURNED, WE WERE UNABLE TO CONFIRM THE REPORTERS INFORMATION THAT WIRE SEGMENTS REMAINED IN THE PATIENT AFTER WIRE EXCHANGE AND WITHDRAWAL; AND IT CANNOT BE DEFINITIVELY CONFIRMED THAT THE WIRE SEGMENTS RETRIEVED ORIGINATED FROM A COOK PRODUCT AS DIFFICULTY WAS ONLY REPORTED FOR THE COMPETITIVE WIRE THAT WAS REPLACED. THE PATIENT SUFFERED MINOR HARM AS A RESULT OF A SURGICAL PROCEDURE TO REMOVE THE WIRE SEGMENT. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING A HEART CATHETERIZATION ANOTHER MANUFACTURER'S MICROPUNCTURE SET AND ANOTHER MANUFACTURER'S GAUGE NEEDLE WERE USED INITIALLY. DURING REMOVAL OF THE WIRE THROUGH THE NEEDLE, THE WIRE BEGAN TO UNRAVEL. THE PHYSICIAN THEN SWITCHED OT A WIRE FROM A MPIS SET. DURING ATTEMPT TO CLOSE THE PUNCTURE SITE, WIRES WERE NOTED TO BE INSIDE THE VESSEL AREA. THE PATIENT WAS SENT TO SURGERY FOR SUCCESSFUL REMOVAL OF THE WIRES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408058 MICROPUNCTURE TRANSITIONLESS ACCESS SET DRE - DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention