BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTOWIRE DEUX

    MDR report key: 6267847 · Received January 20, 2017

    Report

    Report Number
    3008061490-2017-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 18, 2017
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    PMA / PMN Number
    K152991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONCLUDED THE TIP COREWIRE HAD BEEN FRACTURED, BUT BOTH ENDS REMAINED ATTACHED TO THE COIL. THE COMBINED LENGTH OF TIP COREWIRE SECTIONS INDICATED THERE WAS NO PART LEFT IN PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE MET ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL SPECIFICATIONS AT THE TIME IT WAS MANUFACTURED, PRIOR TO SHIPMENT. NO MATERIAL DEFECT WAS NOTICED ON COREWIRE PORTION. THE INVESTIGATION SHOWED THAT THE COREWIRE WAS TWISTED OVER MULTIPLE TURNS. ACCORDING TO IFU: BEFORE AN OPTOWIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED UNDER FLUOROSCOPY. DO NOT TORQUE AN OPTOWIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, VESSEL TRAUMA MAY OCCUR. IF RESISTANCE OCCURS AND THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, DO NOT MOVE OR TORQUE THE OPTOWIRE. STOP THE PROCEDURE, DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE ACTION.

    Description of Event or Problem · 1

    NARRATIVE AS REPORTED BY CLIENT: "DURING A FFR PROCEDURE IN TORTUOUS CIRCUMFLEX, THE OW WENT INTO A COLLATERAL. THE PHYSICIAN PULLED THE WIRE IN ORDER TO REPOSITION IT WHICH INDUCED ITS STRETCHING. THE PHYSICIAN MANAGED TO ENTIRELY REMOVE THE WIRE FROM THE PATIENT WITH AN EMERGENCY PROCEDURE USING A BALLOON. THERE WAS NO CLINICAL IMPACT ON THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49496 OPTOWIRE DEUX PRESSURE GUIDEWIRE DXO OPSENS INC. F1011 OW-0242A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention