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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL
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COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-18-19-20
Device Problems Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 conclusion: the information provided indicated that the balloon was pre-inflated.This is against the instructions for use and a likely cause for the reported observation.The instructions for use caution the user: "do not pre-inflate the balloon." it is unknown if the user applied negative pressure and lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to balloon material damage is failure to apply negative pressure and lubrication to the balloon prior to advancement.The instructions for use advise 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.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in balloon preservation.Prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test 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: 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.Additional comments regarding this report: based on the information provided that the balloon was pre-inflated, against instructions for use, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
 
Event Description
During a dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.The physician wanted to see the size of the balloon when inflated to 3 and 4 atm for the stricture.The nurse told him what french size it would be and not to pre-inflate the balloon prior to advancing it through the endoscope.He pre-inflated the balloon prior to advancing through the endoscope anyway.The nurse said she argued with him about it, but he refused to follow the instructions/guidelines.They were dilating the esophagus and when they inflated the balloon to 3 atm, the nurse saw a pinhole; when they got to 4 atm, the balloon ruptured.They withdrew the balloon and did not use another balloon to finish the procedure.There was no harm done to the patient.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.
 
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a ds-60cc-s was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, inflation of the balloon was attempted.The balloon would not hold pressure and a leakage was observed from a pinhole in the middle of the balloon material.A visual examination of the catheter showed no kinks/bends.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 conclusion: the information provided indicated that the balloon was pre-inflated.This is against the instructions for use and a likely cause for the reported observation.The instructions for use caution the user: "do not pre-inflate the balloon." it is unknown if the user applied negative pressure and lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to balloon material damage is failure to apply negative pressure and lubrication to the balloon prior to advancement.The instructions for use advise 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.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in balloon preservation.Prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test 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: 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.Additional comments regarding this report: based on the information provided that the balloon was pre-inflated, against the instructions for use, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
 
Event Description
During a dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.The physician wanted to see the size of the balloon when inflated to 3 and 4 atm for the stricture.The nurse told him what french size it would be and not to pre-inflate the balloon prior to advancing it through the endoscope.He pre-inflated the balloon prior to advancing through the endoscope anyway.The nurse said she argued with him about it, but he refused to follow the instructions/guidelines.They were dilating the esophagus and when they inflated the balloon to 3 atm, the nurse saw a pinhole; when they got to 4 atm, the balloon ruptured.They withdrew the balloon and did not use another balloon to finish the procedure.There was no harm done to the patient.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.
 
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Brand Name
HERCULES 3 STAGE BALLOON ESOPHAGEAL
Type of Device
KNQ, DILATOR, ESOPHAGEAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key7651609
MDR Text Key112872888
Report Number1037905-2018-00290
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier00827002319271
UDI-Public(01)00827002319271(17)210430(10)W4061121
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue NumberHBD-18-19-20
Device Lot NumberW4061121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENDOSCOPE - UNKNOWN MAKE AND MODEL
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