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

Catalog Number HBD-18-19-20

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation handle, cook ds 60 cc syringe.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.The additional information provided indicated the balloon did not receive lubrication 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.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 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.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.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 a dilation procedure on a patient of unknown age and gender, the physician used a cook hercules 3 stage balloon esophageal.The device was passed through an olympus 190 upper scope and then the nurse inflated to eighteen (18) then to nineteen (19) then to twenty (20) mm.Once reaching to twenty (20) mm, the balloon ruptured.The tip of the balloon popped off leaving part [of the device] in the patient.The nurse pulled the endoscope out and went in to the esophagus with a roth net to retrieve the pieces.No further dilation was done.The nurse confirmed that the patient had trauma from having the endoscope placed multiple times.It was confirmed that no additional actions [other than the retrieval of the device portion] had to be performed on the patient caused by the failure.The nurse indicated negative pressure was pulled and followed inflation steps.The following clarification was received on (b)(6) 2016 regarding the alleged trauma experienced by the patient: "as the scope is placed down the patient, the scope can rub on tissue and irritate.Not caused from the balloon; caused by scope but had to do it this way as the balloon broke.".

• 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: 5636640
• MDR Text Key: 44573071
• Report Number: 1037905-2016-00128
• Device Sequence Number: 1
• Product Code: KNQ
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/11/2016
• 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
• Treatment: OLYMPUS 190 UPPER ENDOSCOPE
• Patient Outcome(s): Required Intervention