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

Catalog Number HBD-15-16.5-18

Device Problems Detachment Of Device Component (1104); Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: olympus endoscope (unknown model), cook ds-60cc dilation syringe.Investigation evaluation: our evaluation of the returned device confirmed the report.The balloon has separated from the catheter approximately 1 cm from the proximal end of the balloon.The balloon could not be inflated in this condition.The internal balloon cannula was returned and it had separated from the catheter.The tip of the device is still attached to the balloon.There is adhesive connecting the distal end of the balloon to the distal tip.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.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.According to the report, lubrication was not applied to the balloon prior to advancement through the endoscope.A possible contributing factor to resistance in advancement and removal from the accessory channel 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.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 and removal.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use contain the following warning: ¿do not advance the balloon dilator if resistance is encountered.Assess the cause of resistance to determine if dilation should be re-attempted.¿ the instructions for use direct the user to apply a vacuum and remove all fluid from the balloon while observing the balloon endoscopically.Then, the user is instructed to remove the deflated balloon from the accessory channel.The application of a vacuum will aspirate all residual fluid from the balloon and ease removal of the balloon from the endoscope.If these instructions are not followed, this could have contributed to the reported observation.The instructions for use contain the following precaution: ¿a compromised balloon may prohibit removal from the endoscope accessory channel.Removal of the endoscope along with the compromised balloon may be required.¿ 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." prior to distribution, all hercules 3 stage balloon 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, 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 an esophageal dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon sheared off in the endoscope [detached in the endoscope].A new hercules 3 stage balloon esophageal was opened and used to complete the procedure.

• 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: 5138675
• MDR Text Key: 27907624
• Report Number: 1037905-2015-00423
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 09/18/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: HBD-15-16.5-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2015
• 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