BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTOWIRE DEUX

    MDR report key: 8683768 · Received June 10, 2019

    Report

    Report Number
    3008061490-2018-00001
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    February 14, 2018
    Report Date
    March 19, 2018
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    PMA / PMN Number
    K152991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROSCOPIC INVESTIGATION REVEALED THAT THE CORE WIRE FAILURE WAS BY THE APPLIED TORSION. THE MOST PROBABLE ROOT CAUSE OF EVENT IS BELIEVED TO BE THE REPORTED TORTUOUS AND CALCIFIED ANATOMY ALONG WITH THE SEVERITY OF THE LESION WHICH CAUSED THE TIP TO BE TRAPPED IN PLACE, AS REPORTED. THE ATTEMPT TO PULL THE WIRE OUT OF THE ENTRAPPED POSITION BY INDUCING A TORSION AND TENSILE FORCE CAUSED THE TIP TO FAIL. (B)(4).

    Description of Event or Problem · 1

    NARRATIVE AS REPORTED BY DISTRIBUTOR: "AT (B)(6) 2018 2:00PM, FFR PROCEDURE WAS PERFORMED TO LAD. DURING SECOND MEASUREMENT, OPTOWIRE WAS TRAPPED AND FRACTURED IN THE LAD. TWO 0.014 INCH GW WAS DELIVERED AND THE FRACTURED PIECE WAS SUCCESSFULLY RETRIEVED. THE DOCTOR SAID THAT SOME CALCIFICATION AND TORTUOUSNESS ARE OBSERVED. THE DOCTOR ALSO SAID CORONARY #10 WAS OCCLUDED BY THE DISSECTION WHICH WAS CAUSED BY THE RETRIEVING PROCEDURE. PCI WAS PERFORMED FOR STENTING AND FINISHED WITH SUCCESS. PATIENT IS STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476816 OPTOWIRE DEUX PRESSURE GUIDEWIRE, PRODUCT CODE: DXO DXO OPSENS INC. F1014 OW-0490D

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention