BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVISIONVLE OPTICAL PROBE, 20MM BALLOON

    MDR report key: 4567462 · Received February 6, 2015

    Report

    Report Number
    3008805841-2015-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    December 14, 2014
    Report Date
    February 5, 2015
    Manufacturer
    NINEPOINT MEDICAL INC.
    Product Code
    NQQ
    PMA / PMN Number
    K120800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED OPTICAL PROBE SHOWED THAT THE BALLOON COMPLETELY DETACHED FROM THE OPTICAL PROBE'S SHEATH AND THAT IT WAS STILL PARTIALLY INFLATED. FOUR MAJOR KINKS WERE NOTED ALONG THE OPTICAL PROBE SHEATH. THE INNER IMAGING LUMEN OF THE OPTICAL PROBE WAS STRETCHED DISTALLY, WHILE THE PROXIMAL PORTION OF THE OPTICAL PROBE WAS FOUND TO BE INTACT. THE DETACHED BALLOON WAS PRESSURIZED AND IT WAS UNABLE TO BE INFLATED NOR DEFLATED WITH A TOUHY BORST ADAPTER AND SYRINGE. THE MOST PROBABLE CAUSE OF THE BALLOON SEPARATION FROM THE OPTICAL PROBE WAS THE ATTEMPT TO REMOVE IT THROUGH THE ENDOSCOPE WORKING CHANNEL WHILE IT WAS STILL PARTIALLY INFLATED. THE SHAFT OF THE OPTICAL PROBE WOULD MOVE FREELY IN THE ENDOSCOPE WORKING CHANNEL, BUT THE BALLOON WOULD BECOME STUCK AT THE WORKING CHANNEL OPENING DUE TO ITS PARTIALLY-INFLATED SIZE. THUS, CAUSING THE OPTICAL PROBE'S SHEATH TO BECOME STRETCHED AND THE BALLOON TO BECOME DETACHED FROM THE ASSEMBLY.

    Description of Event or Problem · 1

    A PATIENT UNDERGOING ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH THE NINEPOINT MEDICAL NVISIONVLE IMAGING SYSTEM AND WITH THE COVIDIEN BARRX RADIOFREQUENCY ABLATION (RFA) SYSTEM. IMAGING WAS COMPLETED WITH A 20 MM NVISIONVLE OPTICAL PROBE. THE BALLOON ON THE OPTICAL PROBE WAS DEFLATED AND REMOVED FROM ENDOSCOPE WORKING CHANNEL. THE BARRX RFA SYSTEM WAS THEN INTRODUCED AND REMOVED FROM THE ENDOSCOPE WORKING CHANNEL AFTER THE RFA WAS COMPLETED. WHILE THE ENDOSCOPE WAS STILL IN PT, THE SAME 20 MM OPTICAL PROBE WAS REINTRODUCED THROUGH THE WORKING CHANNEL FOR POST RFA IMAGING. THE OPTICAL PROBE'S BALLOON WAS RE-INFLATED AND THE PT WAS THEN RE-IMAGED WITH THE NVISION IMAGING SYSTEM. THE TEAM THEN ATTEMPTED TO DEFLATE THE BALLOON FOR REMOVAL FROM THE ENDOSCOPE WORKING CHANNEL, HOWEVER THE BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WERE MADE WITH NO RESULTS. THE CONNECTIONS ON NVISION INFLATION ACCESSORY WERE CHECKED AND FOUND TO BE SECURE. THE TEAM ALSO ATTEMPTED TO DEFLATE THE BALLOON WITH A 35 ML LUER-LOCK SYRINGE. AT THIS POINT, THE PHYSICIAN FELT THAT THE BALLOON HAD DEFLATED ENOUGH, AND WOULD BE ABLE TO PULL IT THROUGH THE ENDOSCOPE WORKING CHANNEL. HOWEVER, WHEN THE OPTICAL PROBE WAS REMOVED COMPLETELY FROM ENDOSCOPE CHANNEL, THE BALLOON WAS NOT ATTACHED TO OPTICAL PROBE. THE ENDOSCOPE WAS REINTRODUCED INTO PT AND THE BALLOON WAS OBSERVED IN ESOPHAGUS. A SNARE WAS INTRODUCED THROUGH ENDOSCOPE WORKING CHANNEL AND USED TO REMOVE THE BALLOON. THE BALLOON AND ENDOSCOPE WERE REMOVED FROM PATIENT AT SAME TIME. NO ADVERSE EFFECTS ON PT WERE NOTED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87158 NVISIONVLE OPTICAL PROBE, 20MM BALLOON NVISIONVLE IMAGING SYSTEM, NQQ NINEPOINT MEDICAL INC. 95101-20 004407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COVIDIEN BARRX HALO 90| ENDOSCOPE