BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISI DOC

    MDR report key: 10949218 · Received December 4, 2020

    Report

    Report Number
    3009600098-2020-00028
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 4, 2020
    Report Date
    February 24, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DOC WAS RECEIVED FOR EVALUATION. PRODUCT ANALYSIS REVEALED THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE DEVICE HISTORY RECORD WAS REVIEWED; THERE WERE NO NON-CONFORMANCES OR REWORK ASSOCIATED WITH THE SERIAL NUMBER. THE UNIT WAS MANUFACTURED IN 2015 AND HAS BEEN IN USE WITHOUT ANY PREVIOUSLY REPORTED EVENTS OR ISSUES INDICATING NO REASON TO SUSPECT A MANUFACTURING/DESIGN RELATED ISSUE. THERE ARE NO SUSPECTED MANUFACTURING/DESIGN/NCMR/CAPA RELATED ISSUES TO REFERENCE AS THE REPORTED ISSUE WAS NOT REPLICATED. THERE ARE NO PREVIOUS COMPLAINTS FOR THIS ISSUE ASSOCIATED WITH THIS SERIAL NUMBER AND THE UNIT HAS NOT BEEN PREVIOUSLY RETURNED FOR REFURBISHMENT. BASED ON THE RESULTS OF THE HARDWARE ANALYSIS, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS IT WAS NOT DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHEN THE DRAGONFLY CATHETER WAS LOADED ONTO THE DOC, THE NURSE FELT AN ELECTRIC SHOCK UP HER ARM. THE PROCEDURE WAS CONTINUED WITH OCT AND COMPLETED WITH NO PATIENT CONSEQUENCES. THE DOC AND SYSTEM WERE LATER TESTED AND EVALUATED BUT NO EVIDENCE OF CURRENT LEAKAGE WAS FOUND. THE DOC WAS REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410203 OPTISI DOC CORONARY OPTICAL COHERENCE TOMOGRAPHY SYSTEM NQQ ABBOTT VASCULAR 100131246 5077820

    Patients

    Seq Age Sex Outcome Treatment
    1