BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE WIRE GUIDED BALLOON DILATOR

    MDR report key: 1853754 · Received September 2, 2010

    Report

    Report Number
    1037905-2010-00445
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 3, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED TO US BY OUR COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(4). EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A LARGE SPLIT IN THE BALLOON MATERIAL. THE SPLIT IS POSITIONED LENGTH-WISE ON THE BALLOON COMPONENT AND IS APPROXIMATELY THE SAME LENGTH OF THE BALLOON. NO SECTION OF THE BALLOON MATERIAL IS MISSING FROM THE DEVICE. WHEN THE BALLOON IS INFLATED WITH WATER, WATER EXITS THE BALLOON MATERIAL AT THE LOCATION OF THE LARGE SPLIT. THE BALLOON WILL NOT HOLD PRESSURE AND CANNOT PERFORM DILATION IN THIS CONDITION. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. CONCLUSIONS: THE ADDITIONAL INFORMATION PROVIDED INDICATED THE BALLOON DID NOT RECEIVE LUBRICATION AND NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A WATER SOLUBLE LUBRICANT TO THE BALLOON TO ALLOW EASIER PASSAGE THROUGH THE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT NEGATIVE PRESSURE IS MANDATORY TO MAINTAIN BALLOON DEFLATION. 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. PRIOR TO DISTRIBUTION, 5 PIECES FROM EACH LOT ARE SUBJECTED TO A TEST TO ENSURE DEVICE INTEGRITY. (FOR LOTS SMALLER THAN 25 PIECES, 2 PIECES ARE TESTED.) DURING THIS TEST, THE OUTER DIAMETER VS. PRESSURE IS MEASURED/VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS TYPE OF REPORT IN AN EFFORT TO HEIGHTEN AWARENESS. THIS WAS BROUGHT TO THE ATTENTION OF THE QUALITY REVIEW BOARD (QRB). NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THE INFORMATION PROVIDED INDICATED THE USER DID NOT FOLLOW THE INSTRUCTIONS. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY ECLIPSE WIRE GUIDED BALLOON DILATOR. THE BALLOON WAS ADVANCED INTO POSITION. THE BALLOON RUPTURED DURING INFLATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PATIENT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE WIRE GUIDED BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY W2541882

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC ALLIANCE INFLATION DEVICE| ENDOSCOPE (UNKNOWN TYPE)