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

Catalog Number HBD-18-19-20

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation device.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During our evaluation the cook ds-60cc-s syringe filled with water was placed on an inflation device and then attached to the balloon inflation port of the device.When pressure was applied to the balloon, water was noticed leaking from the proximal end of the balloon.During a visual inspection, a tiny pinhole in the balloon material was observed.No section of the balloon material is missing from the device.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: 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.A possible contributing factor to balloon damage is application of inadequate negative pressure to the balloon.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.A possible contributing factor to balloon 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.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: "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 instructions for use contain the following warning: ¿do not exceed 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.

Event Description

During an esophageal dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.The device was used for dilation of esophageal stenosis through an endoscope.The balloon was inflated once, and at second attempt, it was confirmed leakage from the balloon.Therefore, the user removed the device from the patient's body and it was confirmed the leakage at the balloon part.Another device was used instead to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 6229714
• MDR Text Key: 64071333
• Report Number: 1037905-2017-00009
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2017

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-18-19-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 ENDOSCOPE, UNKNOWN MODEL