BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 5520775 · Received March 23, 2016

    Report

    Report Number
    3008805841-2016-00001
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 23, 2016
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K143678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE REPORTER DID INDICATE THAT THE DEVICE DID NOT MALFUNCTION DURING THE PROCEDURE, AND THE PHYSICIAN INDICATED THAT IT WAS UNAVOIDABLE, SINCE ANY BALLOON WOULD HAVE LIKELY CAUSED A SMALL MUCOSAL TEAR WITH THE CONDITION OF THE PATIENTS' ESOPHAGUS (STRICTURED) AFTER A CIRCUMFERENTIAL EMR. 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 NVISIONVLE OPTICAL PROBE.

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A 3-MONTH FOLLOW UP AFTER A CIRCUMFERENTIAL ENDOSCOPIC MUCOSAL RESECTION (EMR) TO TREAT HIGH GRADE DYSPLASIA. THE PATIENT HAD AN ESOPHAGEAL STRICTURE, WHICH IS A COMMON COMPLICATION FOLLOWING CIRCUMFERENTIAL EMR. THE PHYSICIAN DECIDED ON A VLE PROCEDURE AND SELECTED 20MM NVISIONVLE OPTICAL PROBE, WHICH CONTAINS A 20 MM BALLOON, FOR THE OCT IMAGING EVALUATION. THE OPTICAL PROBE WAS ADVANCED, INFLATED, AND THE OCT SCAN TOOK PLACE. AFTER OBTAINING THE SCANS AND EVALUATING THE IMAGING, A SMALL MUCOSAL TEAR WAS NOTICED WITHIN THE IMAGING. AFTER THE OPTICAL PROBE'S BALLOON WAS DEFLATED AND REMOVED, THE PHYSICIAN USED HEMOSTATIC CLIPS TO ADDRESS THE SMALL MUCOSAL TEAR. THE PHYSICIAN DID NOT EXPRESS CONCERN, AND LATER STATED THAT IT WAS UNAVOIDABLE, SINCE ANY BALLOON WOULD HAVE LIKELY CAUSED A SMALL MUCOSAL TEAR WITH THE CONDITION OF THE ESOPHAGUS (STRICTURED) AFTER A CIRCUMFERENTIAL EMR. AFTER THE PHYSICIAN DEPLOYED THE HEMOSTATIC CLIPS, HE FINISHED THE CASE IN A NORMAL MANNER BY TAKING A TARGETED BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175247 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95101-20 4705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE ( NO MFGR SPECIFIED)