BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR

    MDR report key: 1881396 · Received October 7, 2010

    Report

    Report Number
    1037905-2010-00499
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    September 10, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LABORATORY EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A VISUAL EXAMINATION OF THE BALLOON MATERIAL CONFIRMED THE PRESENCE OF A LARGE 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 DISTAL END OF THE DILATION BALLOON. WHEN THE BALLOON IS INFLATED WITH WATER, WATER EXITS 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 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 LABORATORY EVAL CONFIRMED THE APPEARANCE OF THE BALLOON RUPTURE SUGGESTS THE DEVICE CAME INTO CONTACT WITH A SHARP OBJECT, PERHAPS DURING USE WITH THE ENDOSCOPE. THE INITIAL REPORTER IS UNSURE IF THE BALLOON WAS LUBRICATED OR IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THIS COULD HAVE CONTRIBUTED TO THE DAMAGED 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 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 A WHILE PARTIALLY OR FULLY INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING PRECAUTION: "DO NOT PREINFLATE 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 WIRE GUIDED 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: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION TAKEN AT THIS TIME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK ENDOSCOPY HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR TO DILATE THE ESOPHAGUS. THE BALLOON WAS NOT HOLDING PRESSURE WHEN THE BALLOON WAS INFLATED. THE BALLOON WAS REMOVED FROM THE ENDOSCOPE AND A DAMAGED AREA DESCRIBED AS A TEAR AND HOLE WAS OBSERVED AT THE DISTAL END OF THE BALLOON. ANOTHER DILATION BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY W2893012

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION DEVICE| OLYMPUS FORWARD VIEWING ENDOSCOPE: MODEL # UNK