BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2172237 · Received June 24, 2011

    Report

    Report Number
    1037905-2011-00432
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    WILSON-COOK MED 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: OUR LAB EVAL OF THE PRODUCTS SAID TO BE INVOLVED CONFIRMED THE REPORT. OUR EVAL RESULTS ARE THE SAME FOR BOTH DEVICES: THE CATHETER TUBING DOES NOT EXHIBIT ANY STRETCHED OR DAMAGED AREAS. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A SMALL IRREGULAR-SHAPED PUNCTURE IN THE BALLOON MATERIAL. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. THE DAMAGED AREA IS LOCATED NEAR THE PROXIMAL END OF THE DILATION BALLOON BUT IS NOT AT THE BALLOON TO CATHETER JOINT. WHEN THE BALLOON IS INFLATED WITH WATER, WATER EXISTS THE BALLOON MATERIAL AT THE LOCATION OF THE DAMAGED AREA. THE BALLOON WILL NOT HOLD PRESSURE AND CANNOT PERFORM IN THIS CONDITION. THE APPEARANCE OF THE DAMAGED AREA SUGGESTS THE BALLOON CAME INTO CONTACT WITH A SHARP OBJECT, PERHAPS A SHARP EDGE OF THE ENDOSCOPE USED WITH THIS BALLOON. A MFG DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORT WAS NOT OBSERVED DURING OUR LAB 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 PRODUCT 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 DAMAGE TO 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 BALLOON DAMAGE 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. DAMAGE TO 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 INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "DURING DILATION, DO NOT INFLATE BALLOON BEYOND THE MAXIMUM INDICATED INFLATION PRESSURE." OVER INFLATION CAN CAUSE DAMAGE TO THE BALLOON DILATOR. ANOTHER POSSIBLE CONTRIBUTING FACTOR IS USING A COMPROMISED INFLATION DEVICE TO INFLATE THE BALLOON. IF THE PRESSURE READING OF THE INFLATION DEVICE IS INACCURATE, THIS COULD CONTRIBUTE TO OVER INFLATION, POSSIBLY RESULTING IN DAMAGE TO THE BALLOON MATERIAL. 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 (REFERENCE MEDWATCH # 1037905-2011-00430). 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 MED 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 MED INC W2963483

    Patients

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