BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEFF PERCUTANEOUS ACCESS SET

    MDR report key: 5922474 · Received September 1, 2016

    Report

    Report Number
    1820334-2016-00855
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 3, 2016
    Manufacturer
    COOK INC
    Product Code
    KGZ
    UDI-DI
    00827002084261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    KGZ ACCESSORIES, CATHETER. INVESTIGATION RESULTS - A VISUAL EXAMINATION OF THE RETURNED USED AND DAMAGED PMG-18SP-60-COPE-NT MANDRIL GUIDE CONFIRMED THAT THE DISTAL SOLDER CONNECTION HAS SEPARATED FROM THE INNER MANDRIL WIRE, RESULTING IN EXTREME COIL ELONGATION. THE SOLDER CONNECTION WAS CONFIRMED TO BE ATTACHED TO THE DISTAL TIP. A REVIEW OF THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROLS, SPECIFICATIONS WAS CONDUCTED TO AID IN THE INVESTIGATION OF THE RELATED PRODUCT COMPLAINT. THE WIRE GUIDE IS INSPECTED 100% FOR SOLDER AND WELD CONNECTIONS BETWEEN THE MANDRIL AND COILED TIP. BASED ON THE EVIDENCE DISPLAYED, IN ADDITION TO THE INFORMATION PROVIDED BY THE CUSTOMER, IT IS REASONABLE TO ASSUME THAT A SECTION OF THE COIL CAUGHT ON THE INTRODUCING NEEDLE, ENCOUNTERING FORCE BEYOND DESIGN REQUIREMENTS WHEN ATTEMPTING TO MANIPULATE AND/OR REMOVE THE MANDRIL GUIDE. AFFIXED TO THE WIRE GUIDE'S PROTECTIVE SHIPPING TUBE IS A CAUTION LABEL THAT PICTORIALLY CAUTIONS AGAINST THE REVERSE PROCESS OF WITHDRAWING THE WIRE GUIDE IN THE NEEDLE AS DAMAGE MAY OCCUR. WE CAN ALSO ADVISE THAT MANIPULATION OF THE WIRE THROUGH THE NEEDLE MAY CAUSE DAMAGE TO THE COIL. PER RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A NEPHROSTOMY INSERTION PROCEDURE AN ATTEMPT WAS MADE TO WITHDRAW A WIRE THROUGH A PUNCTURE NEEDLE, BUT RESISTANCE WAS FELT. THE OPERATOR ATTEMPTED TO ADVANCE THE WIRE THROUGH THE PUNCTURE NEEDLE, BUT WAS UNABLE TO ADVANCE IT. DURING THE ATTEMPTED REMOVAL OF THE WIRE TENSION WAS APPLIED TO THE WIRE. AFTER REMOVAL IT WAS NOTICED THAT THE WIRE HAD ELONGATED. FLUOROSCOPY CONFIRMED THAT NO RESIDUAL WIRE REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572550 NEFF PERCUTANEOUS ACCESS SET KGZ ACCESSORIES, CATHETER KGZ COOK INC N/A 00827002084261

    Patients

    Seq Age Sex Outcome Treatment
    1