BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTOWIRE DEUX

    MDR report key: 6113771 · Received November 18, 2016

    Report

    Report Number
    3008061490-2016-00002
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 15, 2016
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    PMA / PMN Number
    K152991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONCLUDED THE TIP COREWIRE AND COIL HAD BEEN FRACTURED AND SEPARATED. THE COMBINED LENGTH OF THE 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. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE OPTOWIRE PRESSURE GUIDEWIRE. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS BELIEVED TO BE PATIENT CONDITION. THE OPTOWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT USER SHALL NEVER ADVANCE THE WIRE WHEN RESISTANCE IS FELT AND ANY PROGRESSION OF THE WIRE MUST BE DONE UNDER FLUOROSCOPY.

    Description of Event or Problem · 1

    WHILE PERFORMING A FFR PROCEDURE ON A PATIENT WITH A VERY TORTUOUS AND PARTIALLY CALCIFIED # 3 LESION, THE DISTAL PIECE OF THE OPTOWIRE BROKE AND SEPARATED. WHILE THE PHYSICIAN TRIED TO RETRIEVE THE DISTAL PIECE USING A BALLOON CATHETER, A CORONARY DISSECTION OCCURRED. THE SEPARATED PIECE WAS REMOVED FROM THE PATIENT. THE DISSECTION WAS TREATED WITH A PCI PROCEDURE. THE PATIENT IS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763100 OPTOWIRE DEUX PRESSURE GUIDEWIRE DXO OPSENS INC. F1014 OW-0226D

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention