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

Catalog Number HBD-18-19-20

Device Problems Detachment Of Device Component (1104); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product: cook dilation syringe, ds-60cc-s.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.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 indicated that negative pressure and lubrication were not applied to the balloon prior to advancement through the endoscope accessory channel.This is the most likely cause for the reported observation.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." the user is advised to apply lubrication to the balloon material in addition to the tip.The application of lubrication will aid in endoscopic advancement and balloon preservation.Instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." the user indicated that the device was used in the pylorus.Use of the device in the pylorus is against the intended use.The intended use states: ¿this device is used to endoscopically dilate strictures of the esophagus." the instructions for use advise the user: "do not use this device for any purpose other than stated intended use." the user indicated that difficulty was experienced while advancing the balloon catheter through the endoscope accessory channel.A possible contributing factor to balloon advancement/retraction difficulty and balloon detachment is if the balloon comes into contact with a sharp object or a burr in the endoscope channel.The instructions for use advise the user: "do not advance the balloon dilator if resistance is encountered.Assess the cause of resistance to determine if dilation should be reattempted." during removal from the endoscope, the instructions for use caution the user: "caution: a compromised balloon may prohibit removal from the endoscope accessory channel.Removal of the endoscope along with the compromised balloon may be required." prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual inspection and functional testing to ensure device integrity.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.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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: a cook representative has contacted the medical facility involved to promote further education and understanding related to appropriate usage of this product.In addition, the cook representative has been directed to provided further education related to appropriate used of this product based on the information provided that the device was used off label.

Event Description

During a dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.The balloon broke during dilation and while pulling it [the balloon] back through the endoscope, it became detached.It was retrieved with no harm done to the patient.

• 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: 7345660
• MDR Text Key: 102712734
• Report Number: 1037905-2018-00099
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002319271
• UDI-Public: (01)00827002319271(17)201214(10)W4005406
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HBD-18-19-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/19/2018
• Date Device Manufactured: 12/14/2017
• 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): Required Intervention
• Patient Age: 87 YR