BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 4802355 · Received May 26, 2015

    Report

    Report Number
    1037905-2015-00209
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 29, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THERE IS A BREAK IN THE CATHETER APPROXIMATELY 52CM FROM THE PROXIMAL HUB. THERE IS A KINK IN THE CATHETER APPROXIMATELY 134 CM FROM THE PROXIMAL HUB. THERE ARE SCRATCHES IN THE SILVER PRINT APPROXIMATELY 3 CM PROXIMAL TO THE BALLOON. THERE IS A SMALL SECTION OF CATHETER. LESS THAN 1 CM, THAT IS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. ACCORDING TO THE REPORT, LUBRICATION AND NEGATIVE PRESSURE WERE NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY NEGATIVE PRESSURE TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT 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 CATHETER PRESERVATION. THE INSTRUCTIONS FOR USE STATE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." KINKS AND/OR BENDS AND/OR CRACKS IN THE CATHETER CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING USE AND/OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE ADVISE THE USER TO ADVANCE THE DEVICE THROUGH THE ACCESSORY CHANNEL IN SHORT INCREMENTS. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIREGUIDED ESOPHAGEAL-PYLORIC-COLONIC BALLOONS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT NEITHER LUBRICATION OR NEGATIVE PRESSURE WERE APPLIED TO THE DEVICE, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE, A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC WAS USED. THE OUTER HULL OF THE CATHETER BROKE. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED A SMALL SECTION OF CATHETER LESS THAN 1 CM THAT IS MISSING AND WAS NOT INCLUDED IN THE RETURN. INFORMATION REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY. THE LOCATION OF THE MISSING SECTION IS UNKNOWN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339569 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC. W3538207

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE II INFLATION DEVICE| OLYMPUS GIF HQ 190 ENDOSCOPE| COOK DS-60CC-S DILATION SYRINGE