BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAGOLD HIGH PERFORMANCE GUIDEWIRE

    MDR report key: 6916758 · Received October 5, 2017

    Report

    Report Number
    2135342-2017-00003
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    August 31, 2017
    Report Date
    October 11, 2017
    Manufacturer
    HERAEUS MEDICAL COMPONENTS, LLC
    Product Code
    OCY
    PMA / PMN Number
    K150225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED, THEREFORE NO EVALUATION COULD BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED ALL PRODUCTION AND STERILIZATION PROCESSES MET SPECIFICATION. GUIDEWIRE DAMAGE AND BREAKAGE ARE KNOWN COMPLICATIONS THAT MAY OCCUR IF THE GUIDEWIRE IS TORQUED CONTINUOUSLY IN THE SAME DIRECTION. THE RECOMMENDED TORQUEING TECHNIQUE IS ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE, AND NEVER TORQUEING MORE THAN TWO REVOLUTIONS IN THE SAME DIRECTION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PHYSICAL ANALYSIS SHOWS THAT THE RETURNED WIRE IS MISSING APPROXIMATELY 1.5CM OF THE CORE WIRE FROM THE DISTAL TIP (NOT RETURNED). IMAGES SHOW THAT THE PROXIMAL BOND IS VISUALLY CONFORMING AND THAT A TENSILE FORCE WAS APPLIED TO THIS GUIDEWIRE AS THERE ARE ELONGATED SECTIONS OF COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ERCP PROCEDURE, WHILE TORQUEING THE WIRE WITH THE TORQUE ATTACHMENT, THE DISTAL TIP OF THE WIRE BEGAN TO UNRAVEL AND THE TIP OF THE WIRE SEPARATED FROM THE BODY OF THE WIRE IN THE PANCREATIC DUCT, THE TIP WAS RETRIEVED USING A BALLOON. IT IS UNKNOWN HOW MANY TIMES THE WIRE WAS TORQUED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS ALSO REPORTED THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697687 NOVAGOLD HIGH PERFORMANCE GUIDEWIRE ENDOSCOPIC GUIDEWIRE OCY HERAEUS MEDICAL COMPONENTS, LLC 5200 PL00321

    Patients

    Seq Age Sex Outcome Treatment
    1