BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVISIONVLE OPTICAL PROBE

    MDR report key: 5082803 · Received September 16, 2015

    Report

    Report Number
    3008805841-2015-00003
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 19, 2015
    Manufacturer
    NINEPOINT MEDICAL, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K143678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO NINEPOINT MEDICAL, SO NO FAILURE EXAMINATION COULD BE PERFORMED. EXAMINATION OF THE OPTICAL PROBE'S LOT DEVICE HISTORY RECORD SHOWED NO ANOMALIES WITH THAT LOT, NOR ANY OTHER ISSUES THAT POINTED TO THIS TYPE OF FAILURE. THE OPTICAL PROBE BALLOON IS DESIGNED TO BE NON-COMPLIANT, MEANING IT WILL ACHIEVE ITS LABELED DIAMETER AT INFLATION PRESSURE, BUT WILL NOT INCREASE ANY MORE THAN ITS LABELED DIAMETER EVEN WITH ADDITIONAL PRESSURE APPLIED. EACH OPTICAL PROBE BALLOON DIAMETER IS INSPECTED FOR DIAMETER AND LENGTH BY THE SUPPLIER, SO THE RISK IS REMOTE THAT THE BALLOON DIAMETER WOULD BE "BIG" OR GREATER THAN ITS LABELED DIAMETER. THE PRODUCT LABELING DOES STATE THAT THE DEVICE AND ENDOSCOPE CAN BE REMOVED AS A SYSTEM IF A BALLOON APPEARS TO BE DEFLATING SLOWLY OR NOT AT ALL. THE MOST PROBABLE CAUSE OF THE DEVICE FAILURE IS THE BREAK IN THE OPTICAL PROBE'S INNER OPTICAL CORE. THIS MAY HAVE CREATED A BINDING INSIDE THE INNER LUMEN OF THE OPTICAL PROBE, CLOSING OFF THE LUMEN THAT ALLOWS FOR BALLOON INFLATION AND DEFLATION. THIS WOULD MAKE BALLOON DEFLATION DIFFICULT, EVEN IMPOSSIBLE, DEPENDING ON THE SEVERITY OF THE OPTICAL CORE BINDING. DEVICE NOT RETURNED TO COMPANY FOR EVAL

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH THE NINEPOINT MEDICAL NVISIONVLE® IMAGING SYSTEM. IMAGING WAS BEING CONDUCTED WITH A 20MM NVISIONVLE OPTICAL PROBE. THE OPTICAL PROBE'S INNER OPTICAL CORE BROKE DURING MANIPULATION TO CENTER THE OPTICS DURING THE ACQUISITION OF A SCOUT SCAN (A QUICK SCAN UTILIZED DURING CENTERING OF THE OPTICS). THE BALLOON ON THE OPTICAL PROBE WAS UNABLE TO DEFLATE AND THEREFORE COULD NOT BE REMOVED FROM THE ENDOSCOPE WORKING CHANNEL. THE PHYSICIAN TRIED TO DEFLATE THE BALLOON WITH NO SUCCESS. ALTHOUGH THE DEVICE LABELING STATES THE OPTICAL PROBE AND ENDOSCOPE CAN BE REMOVED AS A SYSTEM, THE PHYSICIAN DID NOT WANT TO PULL OUT THE ENDOSCOPE/OPTICAL PROBE AS A UNIT BECAUSE OF CONCERN THAT BALLOON WAS TOO LARGE. THE PHYSICIAN CUT THE PROXIMAL OPTICAL PROBE SHAFT OUTSIDE OF THE ENDOSCOPE TO ALLOW THE BALLOON AND REMAINING DISTAL END OF THE OPTICAL PROBE TO BE PUSHED INTO STOMACH. THE PROXIMAL END OF THE OPTICAL PROBE WAS DISCARDED. THE PHYSICIAN THEN POSITIONED THE DISTAL END OF THE ENDOSCOPE AGAINST THE INFLATED BALLOON. A SCLEROTHERAPY NEEDLE WAS INSERTED DOWN THE ENDOSCOPE WORKING CHANNEL AND USED TO PERFORATE THE BALLOON TO FACILITATE DEFLATION. THE SCLEROTHERAPY NEEDLE WAS EXCHANGED THROUGH THE ENDOSCOPE WORKING CHANNEL WITH RAT-TOOTH GRASPING FORCEPS, WHICH WERE USED TO GRAB THE DISTAL END OF THE OPTICAL PROBE. THE OPTICAL PROBE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT AT THE SAME TIME. NO PATIENT ADVERSE EFFECTS WERE NOTED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611259 NVISIONVLE OPTICAL PROBE NVISIONVLE OPTICAL PROBE NQQ NINEPOINT MEDICAL, INC. 95101-20 4536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention