BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELIMINATOR PET BALLOON DILATOR

    MDR report key: 8851469 · Received August 1, 2019

    Report

    Report Number
    1320894-2019-00284
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 24, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K940965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 000343 IN OPENED ORIGINAL PACKAGING. LOT NUMBER WAS CONFIRMED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, AT THE DISTAL END OF THE DEVICE IS THE RUBBER TIP AND AT THE PROXIMAL END OF THE BALLOON THE INNER WIRE WAS BENT AND EXPOSED DUE TO THE BALLOON RUPTURING. THERE IS A LARGE OBVIOUS SIZED HOLE IN THE BALLOON. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 8 COMPLAINTS REGARDING 9 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; BALLOON DILATION OF A DEEPLY ULCERATED STRICTURE SHOULD BE APPROACHED CAREFULLY IF AT ALL DUE TO A POTENTIAL FOR INCREASED RISK OF PERFORATION. ONCE THE DILATOR IS POSITIONED WITHIN THE STRICTURE, IT SHOULD BE INFLATED WITH WATER OR A MIXTURE OF WATER AND CONTRAST USING THE CONMED INFLATION DEVICE OR SYRINGE WITH A STOPCOCK AND MANOMETER. FOR SINGLE-STAGE TECHNIQUE, THE DILATOR SHOULD BE INFLATED TO THE PRESSURE SPECIFIED FOR THE SELECTED BALLOON SIZE. WHEN THE BALLOON HAS REACHED MAXIMUM PRESSURE, THE STOPCOCK HANDLE SHOULD BE TURNED SO THAT THE PRESSURE MONITOR IS CLOSED OFF TO MAINTAIN BALLOON PRESSURE. FOR 3-STAGE TECHNIQUE, PASS THE BALLOON THROUGH THE STRICTURE UNDER DIRECT VISION POSITIONING THE MIDDLE OF THE BALLOON AT THE CENTER OF THE STRICTURE AND INFLATE THE DILATOR TO 0.3 BAR (5 PSI/ 0.3 ATM) AND MAINTAIN THAT PRESSURE FOR 30 TO 60 SECONDS. INCREASE PRESSURE SUCCESSIVELY FROM 0.3 BAR (5 PSI/ 0.3 ATM) TO STAGE 1, STAGE2 AND STAGE 3 REACHING MAXIMUM INFLATION PRESSURE AS OUTLINED IN THE IFU AND MAINTAIN EACH PRESSURE FOR 30 TO 60 SECONDS. THE3-STAGE PRESSURES FOR THIS DEVICE ARE: STAGE 1 - 3.1BAR (45 PSI/ 3.1 ATM), STAGE 2 - 4.7 BAR (68 PSI/ 4.7 ATM), STAGE 3 - 6.2BAR (90 PSI/ 6.2 ATM). WHEN THE BALLOON HAS REACHED MAXIMUM PRESSURE, THE STOPCOCK HANDLE SHOULD BE TURNED SO THAT THE PRESSURE MONITOR IS CLOSED OFF TO MAINTAIN BALLOON PRESSURE. DO NOT EXCEED MAXIMUM PRESSURE SPECIFIED AS THIS MAY CAUSE THE BALLOON TO BURST. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    CORRECTION: NOTIFICATION VIA MEDWATCH(B)(4) REPORTED THE SURGICAL DATE TO BE 07-17-2019, IT WAS ORGINALLY REPORTED AT (B)(6)2019. CORRECTION HAS BEEN MADE IN B3. MEDWATCH # 5089653 STATES THE PRODUCT CATALOG NUMBER IS 000845, THE PRODUCT WAS ACTUALLY 00343, AS REPORTED ON MEDWATCH # (B)(4). THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORT DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 000343, ESOPHAGEAL BALLOON, POPPED DURING A N EGD WITH ESOPHAGEAL DILATION ON (B)(6) 2019. THEY WERE TRYING TO DILATE A 10MM STRICTURE,THEY WERE USING THE 12MM BALLOON. THERE WERE NO FRAGMENTS THAT HAD TO BE RETRIEVED, HOWEVER AN ESOPHAGEAL LACERATION OCCURRED TO THE PATIENT. IT IS UNSURE IF THE BALLOON CAUSED THIS LACERATION. THE LACERATION WAS CLOSED USED A HEMOCLIP. THERE WAS NO OTHER TREATMENT FOR THE PATIENT. THE PROCEDURE WAS COMPLETED. THE CURRENT STATUS OF THE PATIENT IS RECOVERED. THIS REPORT IS BEING RAISED BECAUSE OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645159 ELIMINATOR PET BALLOON DILATOR ESOPHAGEAL BALLOON DILATOR KNQ CONMED CORPORATION 201805211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other