BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM TTC BILIARY BALLOON DILATOR

    MDR report key: 1983914 · Received February 4, 2011

    Report

    Report Number
    1037905-2011-00056
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 5, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED FOR EVALUATION AND WE CONFIRMED ALL SECTIONS OF THE DEVICE ARE PRESENT. THE PRODUCT LABEL WAS NOT PROVIDED IN THE RETURN. DURING A VISUAL EXAMINATION, WE CONFIRMED DRIED CONTRAST IS LOCATED INSIDE THE BALLOON INFLATION LUMEN OF THE CATHETER. THE CATHETER TUBING DOES NOT EXHIBIT ANY STRETCHED OR DAMAGED AREAS. DURING A FUNCTIONAL EVALUATION, A COOK QUANTUM BILIARY INFLATION DEVICE FILLED WITH WATER WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON. THE BALLOON WOULD NOT INFLATE DUE TO THE DRIED CONTRAST INSIDE THE BALLOON INFLATION LUMEN. THE INFLATION DEVICE WAS REMOVED FROM THE BALLOON DILATOR. DURING OUR EVALUATION, THE CATHETER WAS CUT BEYOND THE LOCATION OF THE DRIED CONTRAST TO FACILITATE AN INFLATION TEST. AN INFLATION TOOL WAS ATTACHED TO THE BALLOON CATHETER AND THE BALLOON WAS INFLATED WITH WATER. THE BALLOON INFLATED PROPERLY, BUT LEAKAGE WAS DETECTED DUE TO A PINHOLE IN THE BALLOON MATERIAL NEAR THE PROXIMAL END. A MANUFACTURING DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORT WAS NOT OBSERVED DURING OUR LABORATORY EVALUATION. 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: PANCREATITIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. THE ADDITIONAL INFO PROVIDED INDICATED THE BALLOON DID NOT RECEIVE LUBRICATION AND NEGATIVE PRESSURE PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THIS IS THE MOST LIKELY CAUSE FOR THIS 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 INSTRUCTIONS FOR USE DIRECT THE USER TO INTRODUCE THE DEFLATED BALLOON INTO THE ACCESSORY CHANNEL. 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 SMALL 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 ALSO CONTAIN THE FOLLOWING PRECAUTION: "THE ENTIRE QUANTUM BALLOON SHOULD BE EXTENDED BEYOND THE TIP OF THE ENDOSCOPE AND BE COMPLETELY VISUALIZED AND POSITIONED BEFORE INFLATION." THE INFO PROVIDED BY THE PHYSICIAN INDICATED THE ELEVATOR OF THE ENDOSCOPE MAY HAVE CAUSED THIS OCCURRENCE. PRIOR TO DISTRIBUTION, A PORTION OF THE LOT IS SUBJECTED TO A TEST TO ENSURE DEVICE INTEGRITY. 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: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFO PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INSTRUCTIONS FOR USE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE BALLOON DILATOR WAS USED TO DILATE THE PAPILLA (8MM FOR 15 SECONDS) AND A BILIARY STENT WAS PLACED. AFTER THE PROCEDURE, THE PHYSICIAN VIEWED FLUOROSCOPIC IMAGES TAKEN DURING THE PROCEDURE. FROM VIEWING THESE IMAGES, WHAT WAS REPORTED TO BE "A LITTLE" CONTRAST LEAKAGE FROM THE BALLOON REPORTEDLY OCCURRED DURING DILATION. THE PHYSICIAN THEN INFLATED THE BALLOON WITH SALINE AND CONFIRMED BALLOON LEAKAGE. THE PHYSICIAN INDICATED THE ELEVATOR OF THE ENDOSCOPE USED DURING THE PROCEDURE MIGHT HAVE CAUSED THE EVENT. THE PHYSICIAN INDICATED SLIGHT PANCREATITIS IS SUSPECTED. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM TTC BILIARY BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W2857627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BOSTON SCIENTIFIC ENCORE INFLATION DEVICE| OLYMPUS 260V ENDOSCOPE| WIRE GUIDE (UNKNOWN TYPE)