BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 8543497 · Received April 24, 2019

    Report

    Report Number
    3008805841-2019-00002
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 24, 2019
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K182616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER DID INDICATE THAT THE DEVICE DID NOT MALFUNCTION DURING THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE ISSUE IS BELIEVED TO HAVE BEEN CAUSED BY DILATION OF AN EXISTING STRICTURE BY THE OPTICAL PROBE BALLOON, WHICH IS A TYPICAL RESPONSE FOR A STRICTURE WHEN IN CONTACT WITH ANY BALLOON. BECAUSE THE NVISIONVLE OPTICAL PROBE WAS NOT RETURNED IT COULD NOT BE PHYSICALLY INSPECTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. RELATED WARNINGS IN THE INSTRUCTIONS FOR USE SPECIFY: THIS DEVICE WILL INFLATE TO LABELED DIAMETER AND THEREFORE, SHOULD NOT BE USED IN ANY ANATOMY WHERE THIS SIZE WOULD BE INAPPROPRIATE. STRICTURES, INFLAMMATORY DISEASE OR ESOPHAGEAL MASSES MAY PREVENT THE ADEQUATE EXPANSION OF THE NVISION VLE OPTICAL PROBE.

    Description of Event or Problem · 1

    THE PHYSICIAN SELECTED A 20 MM NVISIONVLE OPTICAL PROBE, WHICH CONTAINS A 20 MM BALLOON, FOR OCT IMAGING. THE PHYSICIAN SUCCESSFULLY PERFORMED THE PROCEDURE. THERE WERE NO NVISIONVLE OPTICAL PROBE OR IMAGING CONSOLE FAILURES OBSERVED. WHEN THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT, BLEEDING WAS NOTED AND A MUCOSAL TEAR WAS FOUND AT THE SITE OF A PRIOR STRICTURE. THE PHYSICIAN THEN USED AN ENDOSCOPIC CLIP TO STOP THE BLEEDING AND THERE WAS NO ADDITIONAL FOLLOW-UP OR ELONGATION OF PROCEDURE. ACCORDING TO THE PHYSICIAN, THE STRICTURE WAS DILATED BY THE OPTICAL PROBE BALLOON, WHICH IS A TYPICAL RESPONSE FOR A STRICTURE WHEN IN CONTACT WITH ANY BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336853 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95301-M-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention