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

Catalog Number	HBD-10-11-12
Medical Device Problem Codes	Hole In Material (1293); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: boston scientific alliance inflation handle.For the one (1) reported event, the device was returned to cook endoscopy for evaluation and their operating condition was confirmed.Our evaluation of the returned device confirmed the report.The balloon was inflated with a 60 cc syringe and an inflation handle.When the balloon was inflated, there was one pin hole in the balloon near the proximal end of the balloon.The balloon will not hold a steady pressure and dilation performance is likely compromised in this condition due to the slow loss of pressure.No part of the device is missing.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.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.The additional information provided indicated the balloon did not receive lubrication or negative pressure prior to advancement through the endoscope.This is the most likely cause for the reported observation.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.The instructions for use direct the user to apply negative pressure to the catheter to facilitate passage through the endoscope.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 hole in 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.Prior to distribution, all hercules 3 stage balloon 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 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.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 or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicates that during an esophageal dilation, the physician used a cook hercules 3 stage balloon esophageal to treat an esophageal stenosis.At the second attempt of esophageal dilation with the device, the balloon stopped inflating at a certain pressure.The physician removed the device from the endoscope to inspect the device visually, the physician then noticed leakage of saline.The first dilation succeeded; however, the physician actually wanted to dilate the lesion twice with the device.Since the second dilation failed due to damage of the device, the second dilation will be conducted at a later date.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Manufacturer exemption number: e2015051.This mdr report is part of the 227 pilot program.Continued from section d11: boston scientific alliance inflation handle.For the one (1) reported event, the device was returned to cook endoscopy for evaluation and their operating condition was confirmed.Our evaluation of the returned device confirmed the report.The balloon was inflated with a 60 cc syringe and an inflation handle.When the balloon was inflated, there was one pin hole in the balloon near the proximal end of the balloon.The balloon will not hold a steady pressure and dilation performance is likely compromised in this condition due to the slow loss of pressure.No part of the device is missing.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.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.The additional information provided indicated the balloon did not receive lubrication or negative pressure prior to advancement through the endoscope.This is the most likely cause for the reported observation.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.The instructions for use direct the user to apply negative pressure to the catheter to facilitate passage through the endoscope.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 hole in 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.Prior to distribution, all hercules 3 stage balloon 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 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.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 or Problem Description
This report summarizes one malfunction event.A review of the event indicates that during an esophageal dilation, the physician used a cook hercules 3 stage balloon esophageal to treat an esophageal stenosis.At the second attempt of esophageal dilation with the device, the balloon stopped inflating at a certain pressure.The physician removed the device from the endoscope to inspect the device visually, the physician then noticed leakage of saline.The first dilation succeeded; however, the physician actually wanted to dilate the lesion twice with the device.Since the second dilation failed due to damage of the device, the second dilation will be conducted at a later date.There have been no adverse effects to the patient reported.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5609567
• Report Number: 1037905-2016-00089
• Device Sequence Number: 561747
• Product Code: KNQ
• UDI-Device Identifier: 00827002319257
• UDI-Public: (01)00827002319257(17)180429(10)W3568290
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HBD-10-11-12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2016
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2016
• Supplement Report FDA Received Date: 06/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS GIF-Q260 ENDOSCOPE