MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL

Catalog Number HBD-18-19-20

Device Problem Hole In Material (1293)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon failed during the case.The balloon displayed a small pin hole perforation and failed to inflate.

Manufacturer Narrative

Concomitant medical products: boston scientific alliance gun handle 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.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.A possible contributing factor to balloon material failure 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 allow easier passage through the accessory channel.This activity will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user that negative pressure is needed to maintain balloon deflation.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.A balloon material failure 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 state, "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.Monitor endoscopically until the balloon is in the desired position within the stricture." the instructions for use contain the following warning: during dilation do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon.To achieve increasingly larger balloon diameters, increase pressure as indicated on the catheter tag.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 a failure of the balloon material.Prior to distribution, all hercules 3 stage esophageal 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: 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.

Event Description

On 7/16/2015 the following information was provided: during an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon failed during the case.The balloon displayed a small pin hole perforation and failed to inflate.On 8/24/2015 the following information was provided: the balloon was placed in the correct position within the oesophagus and when inflated proved to have a pin hole perforation which prevented inflation.Another device of the same type was used to complete the procedure.

Manufacturer Narrative

Investigation evaluation: our evaluation of the balloon confirmed the report.The balloon was attempted to be inflated but would not hold pressure.A visual inspection found a split in the balloon material approximately 3 cm from the proximal end of the balloon.It would be impossible to inflate the balloon in this condition.No part of the device is missing.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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.A possible contributing factor to balloon material failure 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 allow easier passage through the accessory channel.This activity will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user that negative pressure is needed to maintain balloon deflation.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.A balloon material failure 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 state, "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.Monitor endoscopically until the balloon is in the desired position within the stricture." the instructions for use contain the following warning: during dilation do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon.To achieve increasingly larger balloon diameters, increase pressure as indicated on the catheter tag.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 a failure of the balloon material.Prior to distribution, all hercules 3 stage balloon esophageal 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.Our evaluation of the balloon confirmed the report.The balloon was attempted to be inflated but would not hold pressure.A visual inspection found a split in the balloon material approximately 3 cm from the proximal end of the balloon.It would be impossible to inflate the balloon in this condition.No part of the device is missing.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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.A possible contributing factor to balloon material failure 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 allow easier passage through the accessory channel.This activity will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user that negative pressure is needed to maintain balloon deflation.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.A balloon material failure 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 state, "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.Monitor endoscopically until the balloon is in the desired position within the stricture." the instructions for use contain the following warning: during dilation do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon.To achieve increasingly larger balloon diameters, increase pressure as indicated on the catheter tag.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 a failure of the balloon material.Prior to distribution, all hercules 3 stage balloon esophageal 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.

• 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4974878
• MDR Text Key: 6075266
• Report Number: 1037905-2015-00336
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K061937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-18-19-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1