BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 2992764 · Received February 27, 2013

    Report

    Report Number
    1037905-2013-00074
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 31, 2013
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNQ
    PMA / PMN Number
    K090183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THERE WAS A CRACK IN THE CATHETER APPROX 118 CM FROM THE PROXIMAL HUB. THE EDGES OF THE CRACK MATCHED UP AND THERE WAS NO PART OF THE DEVICE MISSING. THERE WERE 7 KINKS IN THE CATHETER BETWEEN 118 AND 140 CM FROM THE PROXIMAL HUB. THE WIRE GUIDE WAS STILL INSIDE THE CATHETER AND WAS STUCK AND COULD NOT BE REMOVED. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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 PT 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 THE 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 STATES: APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE DEVICE. 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. 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 WIRE GUIDED 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, A COOK REP 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 THE PROCEDURE, A COOK HERCULES 3 STAGE WIREGUIDED BALLOON WAS USED IN THE ESOPHAGUS. NEGATIVE PRESSURE AND LUBRICATION WERE NOT APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE (WHICH IS AGAINST THE INSTRUCTIONS FOR USE). THE BALLOON COULD NOT BE INSERTED INSIDE THE CATHETER OF THE ENDOSCOPE. THE BALLOON BENT INSIDE THE DEVICE (ENDOSCOPE CHANNEL). IMPOSSIBLE TO USE THE DEVICE. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE. UPON RECEIVING THE COMPLETED COMPLAINT COMMUNICATION FORM, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ARRIVING IN FRONT OF THE STENOSIS, THE DOCTOR PUSHED THE HERCULES CATHETER AROUND THE HANDLE OF THE ENDOSCOPE AND BENT IT WHEN HE TRIED TO PUSH IT. IT WAS IMPOSSIBLE FOR THE NURSE TO MOVE THE WIRE GUIDE AND TO MOVE INTO THE ENDOSCOPE. THEY RETRIEVED [REMOVED] ENDOSCOPE AND BALLOON AND USED ANOTHER HERCULES BALLOON WITHOUT PROBLEM. NO SECTION OF THE DEVICE DETACHED INSIDE THE ENDOSCOPE OR PT. OUR LABORATORY EVAL CONFIRMED THE CATHETER IS BROKEN, WHICH HAS BEEN ESTABLISHED AS A REPORTABLE OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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
    84425 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL, INC. W3162329

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GIFQ 145 ENDOSCOPE