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

Catalog Number HBD-8-9-10

Device Problems Hole In Material (1293); Use of Device Problem (1670)

Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  Injury  

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.A review of the device history record could not be conducted because the lot number was not provided.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 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.The instructions for use indicate that "the balloon must be inflated with water only".Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual examination to ensure device integrity.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 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 endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon was inflated to 8 mm with contrast liquid and water.The balloon had a puncture, so the liquid inside put pressure on the balloon, which created a puncture [small perforation] of the esophagus.Per the cook complaint reporting form: "when the nurse inflated the balloon with water and contrast liquid, the doctor saw on the x-ray machine that there was contrast liquid outside of the balloon.They removed the balloon from the patient and outside, they noticed a very small hole on the balloon (with the pressure, this hole may [have] caused a small perforation).The pressure was not known.Clarification was received from the cook sales representative on 07/27/2016: "it seems that the event has created a micro puncture [small perforation].The evacuation under pressure of the contrast liquid through the hole would create a micro puncture at the esophagus [the pressure created a small perforation in the esophagus].Nothing was done to close the micro puncture (because of the poor quality of the mucosa).The patient stayed [in the hospital] for two (2) days with an empty stomach to avoid the extension of the puncture.".

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.A review of the device history record could not be conducted because the lot number was not provided.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 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.The instructions for use indicate that "the balloon must be inflated with water only".Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual examination to ensure device integrity.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 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

This follow up report is being submitted due to the additional information provided by the physician to cook on 09/05/2016.Please see the below narrative for more details: the following information was initially provided to cook on 07/22/2016: "during an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon has been inflated to 8 atm with contrast liquid.The balloon had a puncture so the liquid inside put pressure on the balloon, which created a puncture of the esophagus [small perforation].Per the cook complaint reporting form: "when the nurse inflated the balloon with water and contrast liquid, the doctor saw on the x-ray machine that there was contrast liquid outside the balloon [the instructions for use state: "the balloon must be inflated with water only"].They removed the balloon from the patient and outside, they noticed a very small hole on the balloon (with the pressure, this hole may [be the] cause of a small perforation).The balloon was inflated at 8 mm.No precision about the pressure.Clarification was received from the cook sales representative on 07/27/2016: it's seems that the event has created a micro puncture.The evacuation under pressure of the contrast liquid through the hole would create a micro puncture at the esophagus [the pressure created a small perforation in the esophagus].Nothing was done to close the micro puncture (because of the poor quality of the mucosa).The patient stayed [in the hospital] for 2 days with an empty stomach to avoid the extension of the puncture." clarification was received from the physician on 09/05/2016 in regards to the cause of the perforation: "this is a caustic stenosis, so of course the state of the mucosa is deplorable.On a healthy esophagus, there would probably have been no perforation, but there would have been no more expansion.".

• 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: 5880450
• MDR Text Key: 52247230
• Report Number: 1037905-2016-00298
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HBD-8-9-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• 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
• Patient Outcome(s): Hospitalization