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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 Fluid/Blood Leak (1250); Volume Accuracy Problem (1675); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been received and evaluation is pending.A follow-up report will be sent to capture the results of the evaluation.
 
Event Description
During an esophagogastroduodenoscopy, the physician used a cook hercules 3 stage balloon esophageal.After inflating the balloon successfully up to 2 atm (atmospheres of pressure) and deflating without a problem, they could not inflate it again up to 4 atm; there was a leak in the balloon.The balloon was removed and the procedure was stopped.[there was] no consequence for the patient.Additional information regarding patient outcome has been requested but, to date, has not been provided.
 
Event Description
During an esophagogastroduodenoscopy, the physician used a cook hercules 3 stage balloon esophageal.After inflating the balloon successfully up to 2 atm (atmospheres of pressure) and deflating without a problem, they could not inflate it again up to 4 atm; there was a leak in the balloon.The balloon was removed and the procedure was stopped.[there was] no consequence for the patient.The following additional information was received on 09-nov-2018: 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.A functional test could not be performed due to the condition of the returned device.A visual examination of the balloon showed a hole in the balloon material.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 additional information provided from the user indicated the instructions for use were not followed in regard to setup and inflation of the device.This is the most likely cause for the reported observation.Specifically the user indicated the following: 1.Negative pressure was not applied to the balloon prior to advancement through the endoscope accessory channel.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 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." 2.Lubrication was not applied to the balloon prior to advancement through the endoscope accessory channel.Failure to apply lubrication to the balloon prior to advancement can result in balloon material damage.The instructions for use direct the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." the application of lubrication will aid in endoscopic advancement and balloon preservation.3.The balloon was inflated using a medtronic everest 30 inflation device.The medtronic everest 30 inflation device has a 20 cc syringe which is incompatible with the dilation balloon and should not be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure." 4.Contrast was used to inflate the balloon.The instructions for use advise the user: "the balloon must be inflated with water only." prior to distribution, all hercules 3 stage balloons esophageal 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 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 negative pressure and lubrication were not applied prior to advancement through the endoscope, the balloon was inflated with an incompatible inflation device, and that contrast was used to inflate the balloon against the instructions for use, 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.
 
Manufacturer Narrative
Evaluation findings: 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 additional information provided from the user indicated the instructions for use were not followed in regard to setup and inflation of the device.This is the most likely cause for the reported observation.Specifically the user indicated the following: 1.Negative pressure was not applied to the balloon prior to advancement through the endoscope accessory channel.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 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." 2.Lubrication was not applied to the balloon prior to advancement through the endoscope accessory channel.Failure to apply lubrication to the balloon prior to advancement can result in balloon material damage.The instructions for use direct the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." the application of lubrication will aid in endoscopic advancement and balloon preservation.3.The balloon was inflated using a medtronic everest 30 inflation device.The medtronic everest 30 inflation device has a 20 cc syringe which is incompatible with the dilation balloon and should not be used to inflate it.The instructions for use advise the user "attach the balloon to a 60 ml (cc) inflation device with gauge to monitor balloon pressure." 4.Contrast was used to inflate the balloon.The instructions for use advise the user: "the balloon must be inflated with water only." prior to distribution, all hercules 3 stage balloons esophageal 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 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 negative pressure and lubrication were not applied prior to advancement through the endoscope, the balloon was inflated with an incompatible inflation device, and that contrast was used to inflate the balloon against the instructions for use, 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.
 
Event Description
During an esophagogastroduodenoscopy, the physician used a cook hercules 3 stage balloon esophageal.After inflating the balloon successfully up to 2 atm (atmospheres of pressure) and deflating without a problem, they could not inflate it again up to 4 atm; there was a leak in the balloon.The balloon was removed and the procedure was stopped.[there was] no consequence for the patient.The following additional information was received on 09-nov-2018: 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 Key7971611
MDR Text Key126098558
Report Number1037905-2018-00487
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier00827002319271
UDI-Public(01)00827002319271(17)200920(10)W3918252
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/20/2020
Device Catalogue NumberHBD-18-19-20
Device Lot NumberW3918252
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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