BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTOWIRE DEUX

    MDR report key: 8682639 · Received June 10, 2019

    Report

    Report Number
    3008061490-2019-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 24, 2018
    Manufacturer
    OPSENS INC.
    Product Code
    DXO
    PMA / PMN Number
    K152991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESUBMISSION BECAUSE IT WAS INITIALLY SUBMITTED TO THE TEST ENVIRONMENT (ESGTEST.FDA.GOV) BY ERROR. ORIGINAL REPORT DATE WAS KEPT. [(B)(4)].

    Description of Event or Problem · 1

    NARRATIVE OF EVENT, AS DESCRIBED BY ZEON (MARKET AUTHORIZATION HOLDER IN (B)(4)): "FFR WAS TRIED FOR RXA#2-3. DPR WAS TRIED THEN. DURING DOCTOR'S OPERATION, OPTOWIRE WAS STRAYED INTO RCA BRANCH. THE DOCTOR TRIED TO PUSH THE OW BUT UNFORTUNATELY HAD STUCK. SINCE THE COIL WAS STRETCHED, THE DOCTOR CONSIDERED THAT WITHDRAWING WIRE WILL BE THE TROUBLE BECAUSE IT WILL REACH TO AO. THE DOCTOR PERFORMED EMERGENCY PCI TO CUT THE STUCK OW BY ROTABLATOR THEN PRESSED THE FRAGMENT TO THE CORONARY WALL BY STENT. THE DOCTOR CONSIDERED THAT THIS WAS CAUSED BY THE PROCEDURE, NOT BY THE PRODUCT'S PROBLEM.". INVESTIGATION RESULTS BY ZEON, AS DESCRIBED BY ZEON: "COIL WAS STRETCHED. HOWEVER, NO CORROSION OBSERVED. RETURNED MATERIAL: OW, NO GF CONNECTOR, NO FOIC. COREWIRE WAS FRACTURED AT 16MM POSITION FROM DISTAL END.". PATIENT CONDITIONS THAT COULD HAVE IMPACTED THE PROCEDURE: MODERATE CALCIFICATION AND MODERATE TORTUOUSNESS OF VESSELS. HEALTH STATUS OF THE PATIENT AFTER THE PROCEDURE: CONFIRMED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476075 OPTOWIRE DEUX PRESSURE GUIDEWIRE DXO OPSENS INC. F1014 OW-0655D

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention