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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-18-19-20
Device Problem Hole In Material
Event Date 05/08/2017
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. During a functional test, a cook ds-60cc-s dilation syringe was filled with water and attached to the balloon inflation port. The syringe was placed into an inflation handle, and negative pressure was applied to the balloon. After applying negative pressure, inflation of the balloon was attempted. The balloon would not hold pressure and a leakage was observed from a hole in the middle of the balloon material. A visual examination of the catheter showed no kinks or bends. 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 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 hole in the balloon material can occur if inadequate lubricant is applied prior to advancement through the endoscope. The instructions for use say: ¿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. A hole in the balloon material can occur if inadequate negative pressure is applied. 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 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 also contain the following precaution: ¿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. ¿ 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 a failure of the balloon material. Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual inspection and functional testing to ensure device integrity. The functional tests consist of a flow and leak test. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. 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. There was a hole in the balloon.

 
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Brand NameHERCULES 3 STAGE BALLOON ESOPHAGEAL
Type of DeviceKNQ, 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 Key6608466
Report Number1037905-2017-00348
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/02/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-18-19-20
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/08/2017
Device Age2 mo
Event Location Hospital
Date Manufacturer Received05/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/20/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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