BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR

    MDR report key: 1950140 · Received December 8, 2010

    Report

    Report Number
    1037905-2010-00665
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 8, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(6) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE 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 THE LOT REMAINED IN FINISHED GOODS INVENTORY. CONCLUSIONS: THE ADD'L INFO PROVIDED INDICATED THE BALLOON DILATOR DID NOT RECEIVE LUBRICATION 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 LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. 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 BALLOON RUPTURE 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, SUCH AS A RUPTURE OR SPLIT. 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 A RUPTURE OF THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE 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: THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THIS TYPE OF OCCURRENCE IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED AND 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 DILATION, THE PHYSICIAN USED A COOK ENDOSCOPY HERCULES 3 STAGE ESOPHAGEAL BALLOON. THE BALLOON WAS INFLATED WITH STERILE WATER AND RUPTURED DURING USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR KNQ, ESOPHAGEAL DILATOR KNQ COOK ENDOSCOPY W2860990

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE: MODEL NUMBER NOT PROVIDED| COOK DS-60CC INFLATION DEVICE