BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NVISION VLE OPTICAL PROBE

    MDR report key: 4778850 · Received April 21, 2015

    Report

    Report Number
    3008805841-2015-00002
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 21, 2015
    Manufacturer
    NINEPOINT MEDICAL INC.
    Product Code
    NQQ
    PMA / PMN Number
    K143678
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED OPTICAL PROBE WAS ANALYZED AS PART OF THIS COMPLAINT INVESTIGATION. THE OPTICAL PROBE WAS RETURNED TO NINEPOINT MEDICAL WITH THE BALLOON DETACHED. THE PROXIMAL END OF THE OPTICAL PROBE APPEARED TO BE FINE WITH NO KINKS OR OTHER DAMAGE NOTED. THE DETACHED BALLOON WAS PROLAPSED OVER THE DISTAL TRANSITION ZONE. THE BALLOON APPEARED TO BE STRETCHED FROM THE PROXIMAL END TOWARDS THE DISTAL END OF THE BALLOON. THE BALLOON WAS NOTED TO BE SOMEWHAT INFLATED, BUT AT A LOWER PRESSURE THAN FULL EXPANSION PRESSURE (APPROX 15 PSI), AS NOTED BY THE WRINKLING ON THE SIDES AND CONES OF THE BALLOON. THERE WAS A TENSILE BOND FAILURE OF THE INNER AND OUTER LUMEN AT THE JUNCTION OF THE SOFT PROXIMAL BALLOON BOND SEGMENT. THE INNER LUMEN WAS STRETCHED OVER THE TORQUE COIL, WHICH MAY HAVE RESULTED IN AIR BEING TRAPPED IN THE BALLOON AFTER THE BALLOON WAS DAMAGED AND WAS DETACHED FROM THE OPTICAL PROBE. THE DAMAGE TO THE OPTICAL PROBE IS INDICATIVE OF ATTEMPTING TO REMOVE A PARTIALLY- OR FULLY-INFLATED BALLOON THROUGH THE 2.8MM WORKING CHANNEL OF AN ENDOSCOPE, WHERE THE BALLOON WILL NOT FIT THROUGH THE CHANNEL AND GREATER TENSION IS APPLIED BY THE PHYSICIAN, RESULTING IN A TENSILE FAILURE IN THE BALLOON SHEATH SUBASSEMBLY. THIS TENSILE FAILURE ALLOWED THE BALLOON TO SEPARATE FROM THE OPTICAL PROBE. IT IS BELIEVED THAT THE OPTICAL PROBE WAS ATTEMPTED TO BE REMOVED FROM THE ENDOSCOPE WHILE THE BALLOON WAS STILL FULLY- OR PARTIALLY-INFLATED, CAUSING THE OPTICAL PROBE SHEATH TO BECOME STRETCHED AND THE BALLOON TO BECOME DETACHED FROM THE REMAINDER OF THE OPTICAL PROBE.

    Description of Event or Problem · 1

    THE 20MM OPTICAL PROBE USED IN THIS PROCEDURE YIELDED 4 SCOUT SCANS AND A FULL SCAN. THE NURSE WAS ASKED BY THE PHYSICIAN TO DEFLATE THE BALLOON AFTER THE FINAL FULL SCAN. THE NURSE USED THIS OPPORTUNITY TO TRAIN ANOTHER NURSE ON THE USAGE OF THE INFLATION ACCESSORY. AS THIS INSTRUCTION PROGRESSED, IT WAS NOTED THAT THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE OPTICAL PROBE FROM THE ENDOSCOPE AT WHICH TIME WHERE THE OPTICAL PROBE BROKE. THE PHYSICIAN LOOKED AT THE WHITE LIGHT ENDOSCOPE IMAGE AND OBSERVED THE BALLOON HAD SEPARATED FROM THE OPTICAL PROBE AND WAS STILL IN THE PT'S STOMACH. THIS WAS VERIFIED BY NINEPOINT MEDICAL PERSONNEL OBSERVING THE PROCEDURE BY HEARING THE PHYSICIAN ACKNOWLEDGE THAT "THE BALLOON IS STILL IN THERE". THE DAMAGED OPTICAL PROBE WAS REMOVED FROM THE ENDOSCOPE, FOLLOWED BY THE PHYSICIAN USING A SNARE TO SECURE THE BALLOON AND REMOVE IT WITHOUT INCIDENT OR INJURY TO THE PT. THE PHYSICIAN NOTED THAT THE DETACHED BALLOON STILL APPEARED TO BE AT LEAST PARTIALLY-INFLATED WHEN HE APPROACHED IT WITH THE SNARE, BUT WAS ABLE TO DEFLATE IT WITH THE SNARE PRIOR TO REMOVAL. THE PT CONDITION WAS LATER CONFIRMED BY THE PHYSICIAN AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265405 NVISION VLE OPTICAL PROBE OPTICAL PROBE NQQ NINEPOINT MEDICAL INC. 95101-20 004466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE