BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTOWIRE DEUX

    MDR report key: 8686626 · Received June 11, 2019

    Report

    Report Number
    3008061490-2018-00004
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    September 3, 2018
    Report Date
    September 28, 2018
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    PMA / PMN Number
    K152991
    Product Problem
    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 WAS FRACTURED AND SEPARATED. 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. THE ATTEMPT TO PULL THE WIRE OUT OF THE ENTRAPPED POSITION BY INDUCING A TORSION AND TENSILE FORCE CAUSED THE TIP TO FAIL. 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. ON (B)(6) 2019: THIS REPORT IS A RESUBMISSION BECAUSE IT WAS INITIALLY SUBMITTED TO THE TEST ENVIRONMENT (ESGTEST.FDA.GOV) BY ERROR. ORIGINAL MANUFACTURER REPORT # AND ORIGINAL REPORT DATE WERE KEPT. [(B)(4)].

    Description of Event or Problem · 1

    NARRATIVE AS REPORTED BY CLIENT: "USED FOR STENTED LEFT ANTERIOR DESCENDING ARTERY. NOT BIFURCATED. THE PHYSICIAN NOTICED THAT THE OPTOWIRE HAD STUCK DURING OPERATION. HE PULLED THE OPTOWIRE LIGHTLY, BUT THE DISTAL TIP HAS FRACTURED. HE TRIED TO WITHDRAW THE REMAINED FRAGMENT. THE FRAGMENT WAS RETRIEVED SUCCESSFULLY BY SNARE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479647 OPTOWIRE DEUX PRESSURE GUIDEWIRE DXO OPSENS INC. F1014 OW-0635D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention