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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-15-16.5-18
Device Problem Hole In Material
Event Date 10/26/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: boston scientific inflation device. Investigation evaluation: our evaluation of the returned device confirmed the report. The balloon was inflated with a 60 cc syringe and an inflation handle. The balloon would not maintain pressure due to two pinholes near the proximal end of the balloon where two streams of water can be seen exiting the balloon. 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 balloon material failure 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 allow easier passage through the accessory channel. This activity will aid in endoscopic advancement and balloon preservation. The instructions for use advise the user that negative pressure is needed to maintain balloon deflation. 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 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. " the instructions for use contain the following warning: during dilation do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon. To achieve increasingly larger balloon diameters, increase pressure as indicated on the catheter tag. 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. 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. To dilate the esophagus, the physician gradually raised pressure to inflate the balloon but the balloon would not inflate. The physician removed the balloon from the endoscope. He checked the balloon and confirmed [there were] two (2) pin holes; so he replaced it with another one [device] with a different lot number to complete the procedure.

 
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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 Key5229660
Report Number1037905-2015-00502
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-15-16.5-18
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2015
Device Age5 mo
Event Location Hospital
Date Manufacturer Received10/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/27/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/17/2015 Patient Sequence Number: 1
Treatment
OLYMPUS ENDOSCOPE (UNKNOWN MODEL)
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