BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2172294 · Received June 24, 2011

    Report

    Report Number
    1037905-2011-00430
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DURING A VISUAL EXAMINATION OF THE PRODUCT SAID TO BE INVOLVED, WE CONFIRMED THE BALLOON IS IN THE DEFLATED POSITION AND DOES NOT SHOW ANY EVIDENCE OF NOTICEABLE DAMAGE. THE CATHETER TUBING DOES NOT EXHIBIT ANY STRETCHED OR DAMAGED AREAS. DURING A FUNCTIONAL EVAL, A COOK QUANTUM INFLATION DEVICE FILLED WITH WATER WAS USED TO INFLATE THE BALLOON. THE BALLOON INFLATED PROPERLY. A VISUAL EXAMINATION OF THE INFLATED BALLOON DILATOR CONFIRMED THE PRESENCE OF A SMALL HOLE IN THE BALLOON MATERIAL. THE HOLE IS LOCATED NEAR THE MIDDLE OF THE DILATION BALLOON. A SMALL AND STEADY STREAM OF WATER EXITS THE BALLOON AT THE LOCATION OF THE SMALL HOLE. THE BALLOON WILL NOT HOLD A STEADY PRESSURE AND DILATION PERFORMANCE IS LIKELY COMPROMISED IN THIS CONDITION DUE TO THE SLOW LOSS OF PRESSURE. THE INFLATION DEVICE WAS USED TO DEFLATE THE BALLOON, REMOVING THE WATER FROM THE BALLOON DILATOR. A MFG DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORT WAS NOT OBSERVED DURING OUR LABORATORY EVAL. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCTS FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: THE ADD'L INFO PROVIDED INDICATED THE BALLOON DID NOT RECEIVE LUBRICATION PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE .THIS IS THE MOST LIKELY CAUSE FOR THE HOLE IN THE BALLOON MATERIAL. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE REPORTER WAS UNABLE TO SPECIFY IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON DEVICE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO A HOLE IN THE BALLOON MATERIAL IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY NEGATIVE PRESSURE TO THE CATHETER TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. A HOLE IN THE BALLOON MATERIAL CAN OCCUR IF THE BALLOON IS INFLATED PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE OR IF THE BALLOON IS INFLATED WHILE PARTIALLY OR FULLY INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT PRE-INFLATE THE BALLOON." THE INSTRUCTIONS FOR USE DIRECT THE USER TO ENSURE THE BALLOON IS COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION. THE INFO RELATED TO A HARD BELLY (I.E. ABDOMEN) WAS REVIEWED WITH CLINICAL PERSONNEL. HARDENING OF THE ABDOMEN MOST LIKELY OCCURRED AS A RESULT OF INSUFFLATION (AIR INTRODUCED INTO THE GASTROINTESTINAL TRACT DURING AN ENDOSCOPIC PROCEDURE). AN EXTENDED PROCEDURE WOULD LIKELY REQUIRE INSUFFLATION, WHICH IS EXPECTED. INSUFFLATION IS TYPICALLY RESOLVED WHILE IN RECOVERY BY THE PT SIMPLY EXPELLING THE EXCESS AIR. PRIOR TO DISTRIBUTION, ALL QUANTUM TTC ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A DILATION OF AN ESOPHAGEAL STRICTURE, A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED. WHEN THE BALLOON WAS INFLATED TO FULL PRESSURE (50 PSI), THE BALLOON LEAKED. THE BALLOON DILATOR WAS REMOVED AND ANOTHER COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED. THIS BALLOON ALSO LEAKED AT FULL PRESSURE (REFERENCE MEDWATCH # 1037905-2011-00431). A THIRD COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED AND AGAIN LEAKAGE AFTER INFLATION TO FULL PRESSURE OCCURRED (REFERENCE MEDWATCH # 1037905-2011-00432). A FOURTH COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED AND THE BALLOON MAINTAINED PRESSURE. WHEN THIS BALLOON WAS REMOVED (BALLOON MUST BE EVACUATED OF WATER TO FACILITATE REMOVAL FROM PT AND ENDOSCOPE), THE USER NOTICED THE BALLOON MATERIAL EXHIBITED A TORN AREA AND LEAKAGE OUTSIDE THE ENDOSCOPE WAS OBSERVED. AT THIS POINT, THE PROCEDURE WAS REPORTEDLY TAKING TOO LONG, SO THE PROCEDURE WAS CONCLUDED. THE PT HAD BEEN UNDER SEDATION FOR A LONG PERIOD OF TIME AND THE BELLY WAS VERY HARD WHEN THE PROCEDURE WAS CONCLUDED. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED BUT THE PT WILL HAVE TO COME BACK FOR COMPLETION OF THE DILATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL, INC. W2957163

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL)| BOSTON SCIENTIFIC ALLIANCE SYRINGE| BOSTON SCIENTIFIC ALLIANCE INFLATION GUN