BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 5793858 · Received July 14, 2016

    Report

    Report Number
    1037905-2016-00217
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 11, 2016
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    UDI-DI
    00827002487321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EXEMPTION NUMBER: E2015051. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM. CONTINUED FROM SECTION D.11: COOK DS-60CC-S SYRINGE, PENTAX EG-29-I10 A112592 ENDOSCOPE. FOR THE ONE (1) REPORTED EVENT, THE DEVICE WAS RETURNED TO COOK ENDOSCOPY. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. DURING A VISUAL INSPECTION, IT WAS CONFIRMED THAT THERE IS A RUPTURE IN THE BALLOON MATERIAL. THE BALLOON MATERIAL IS RUPTURED STARTING AT THE PROXIMAL END OF THE BALLOON AND IS SPLIT TOWARDS THE MIDDLE SECTION OF THE BALLOON. THE SPLIT IN THE BALLOON MATERIAL IS ABOUT 4 CM IN LENGTH. DUE TO THE CONDITION OF THE BALLOON MATERIAL A FUNCTIONAL TEST COULD NOT BE PERFORMED. NO SECTION OF THE BALLOON MATERIAL WAS MISSING. THERE WERE SEVERAL KINKS IN THE CATHETER OF THE DEVICE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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. 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. A POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL DAMAGE IS INADEQUATE LUBRICATION OF THE BALLOON WITH A LUBRICATING AGENT. 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. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO BALLOON MATERIAL DAMAGE IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER "TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE CATHETER." 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. DAMAGE TO 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 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. 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 DAMAGE TO THE BALLOON MATERIAL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE BALLOON ESOPHAGEAL ARE SUBJECTED TO A VISUAL EXAMINATION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. UPON INFLATION OF THE BALLOON, THE BALLOON LEAKED. THE EVENT INVOLVED ONE (1) PATIENT WITH NO CONSEQUENCES TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448229 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY 00827002487321

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX EG-29901, (B)(4) ENDOSCOPE| PENTAX EG-29901, (B)(4) ENDOSCOPE