BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 7354822 · Received March 20, 2018

    Report

    Report Number
    3008805841-2018-90002
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 20, 2018
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    UDI-DI
    00859591006072
    PMA / PMN Number
    K153479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 20 MM NVISIONVLE® OPTICAL PROBE WAS RETURNED TO NINEPOINT MEDICAL FOR EVALUATION. BALLOON FOLD LINES WERE OBSERVED, SUGGESTING IT WAS PULLED ABOUT TWO-THIRDS OF ITS LENGTH INTO THE ENDOSCOPE. THE DISTAL ONE-THIRD OF THE BALLOON WAS NOT FOLDED BUT INVERTED. THIS SUGGESTS THAT A PILLOW OF AIR WAS PRESENT AT THE TIP WHICH PREVENTED PASSAGE OF THE OPTICAL PROBE INTO THE ENDOSCOPE. THE SEPARATION OF THE BALLOON FROM THE SHEATH OCCURS WHEN THE BALLOON IS INSUFFICIENTLY EVACUATED PRIOR TO REMOVAL. THE EVIDENCE INDICATES THAT THE MAJORITY OF THE BALLOON WAS INSIDE THE ENDOSCOPE AT THE TIME OF FAILURE AND THUS NO INTERNAL COMPONENTS OF THE OPTICAL PROBE HAD COME INTO CONTACT WITH THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. RELATED WARNINGS AND PRECAUTIONS IN THE INSTRUCTIONS FOR USE SPECIFY: 1) WHEN DRAWING THE OPTICAL PROBE INTO THE ENDOSCOPE, IF PILLOWING IS OBSERVED, STOP AND EITHER RE-INFLATE AND DEFLATE, OR REMOVE THE OPTICAL PROBE AND SCOPE AS A SYSTEM. 2) USE CARE WHEN MANIPULATING THE ENDOSCOPE WHILE THE BALLOON GUIDE SHEATH IS INFLATED. EXTREME MANIPULATIONS OF THE ENDOSCOPE MAY RESULT IN BREAKAGE OF THE OPTICAL PROBE. 3) THIS DEVICE WILL INFLATE TO LABELED DIAMETER AND THEREFORE, SHOULD NOT BE USED IN ANY ANATOMY WHERE THIS SIZE WOULD BE INAPPROPRIATE. 4) STRICTURES, INFLAMMATORY DISEASE OR ESOPHAGEAL MASSES MAY PREVENT THE ADEQUATE EXPANSION OF THE OPTICAL PROBE.

    Description of Event or Problem · 1

    THE PHYSICIAN SELECTED A 20 MM NVISIONVLE® OPTICAL PROBE, WHICH CONTAINS A 20 MM BALLOON, FOR THE OCT IMAGING EVALUATION. THE OPTICAL PROBE WAS INSERTED THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE, INFLATED, AND THE IMAGING PROCEDURE WAS PERFORMED SUCCESSFULLY. AT THE END OF THE IMAGING PROCEDURE, THE TECHNICIAN DEFLATED THE 20 MM BALLOON AND BEGAN TO REMOVE THE OPTICAL PROBE. AT THIS POINT, IT WAS NOTED THAT THE OPTICAL PROBE HAD DIFFICULTY BEING REMOVED FROM THE ENDOSCOPE. THE OPTICAL PROBE WAS REMOVED FROM ENDOSCOPE, HOWEVER THEY NOTICED THAT THE BALLOON WAS DETACHED FROM THE OPTICAL PROBE AND LODGED IN THE ENDOSCOPE CHANNEL. THE ENDOSCOPE WITH LODGED BALLOON WAS REMOVED FROM PATIENT. IT WAS OBSERVED THAT THE OPTICAL PROBE WAS LODGED IN THE ENDOSCOPE AND THE PROXIMAL END OF THE BALLOON WAS STILL PARTIALLY INFLATED. IT IS PRESUMED THAT THE BALLOON WAS NOT FULLY DEFLATED BEFORE TRYING TO REMOVE THE OPTICAL PROBE. THE OPTICAL PROBE'S BALLOON WAS REMOVED FROM THE ENDOSCOPE CHANNEL AND THE ENDOSCOPE WAS REINSERTED. UPON FURTHER EXAMINATION OF PATIENT AFTER THE OCT IMAGING PROCEDURE, TWO BLEEDING MUCOSAL TEARS NEAR THE ESOPHAGOGASTRIC JUNCTION WERE NOTICED. THE BLEEDING WAS STOPPED WITH 2 HEMOSTATIC CLIPS AT THE SITE. THERE WERE NO STRICTURES OR HERNIA NOTICED IN THAT AREA. THE PHYSICIAN WAS NOT CONCERNED ABOUT THE BLEEDING, AND THE PROCEDURE INCLUDING SUBSEQUENT BIOPSY WAS COMPLETED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197732 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95301-M-20 5263 00859591006072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention