BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 8508898 · Received April 12, 2019

    Report

    Report Number
    3008805841-2019-00001
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 11, 2019
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    UDI-DI
    00859591006065
    PMA / PMN Number
    K182616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 EITHER INFLATING THE OPTICAL PROBE BALLOON WITHIN A STRICTURE CAUSING A MECHANICAL TEAR OR THE PATIENT EXCESSIVE COUGHING WHILE THE OPTICAL PROBE BALLOON WAS INFLATED. 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: 1) THIS DEVICE WILL INFLATE TO LABELED DIAMETER AND THEREFORE, SHOULD NOT BE USED IN ANY ANATOMY WHERE THIS SIZE WOULD BE INAPPROPRIATE. 2) 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 17 MM NVISIONVLE OPTICAL PROBE, WHICH CONTAINS A 17 MM BALLOON, FOR OCT IMAGING. OPTICAL PROBE BALLOON WAS INFLATED TO 5PSI TO EVALUATE EVIDENCE OF STRICTURES, WHICH WERE NOTED TO BE ABSENT. THE BALLOON WAS THEN INFLATED TO 15 PSI. DURING THE VLE PROCEDURE, IT WAS NOTICED THAT THE PATIENT HAD A PROXIMAL ESOPHAGEAL WALL TEAR. UPON THIS OBSERVATION, THE VLE PROCEDURE WAS ENDED AND THE OPTICAL PROBE BALLOON WAS DEFLATED. PATIENT WAS FURTHER INSPECTED AND THE OBSERVED TEAR IN THE ESOPHAGEAL WALL WAS DETERMINED TO BE MOST LIKELY A PERFORATION. PERFORATION CLOSURE WAS ACHIEVED WITH ENDOSCOPIC CLIPS. PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION ON THE DAY OF PROCEDURE ((B)(6) 2019). THE FOLLOWING DAY ((B)(6) 2019), PERFORMING PHYSICIAN REVIEWED THE ESOPHAGRAM, REPORTING THAT THE ESOPHAGRAM SHOWED THAT THE TEAR WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300897 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 94301-M-17 005346 00859591006065

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R