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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 Problems Hole In Material; Use of Device Problem
Event Date 02/19/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: cook ds 60 cc syringe. For the one (1) reported event, the device was returned to cook endoscopy and the operating condition was confirmed. Our evaluation of the returned device confirmed the report. The balloon was inflated with a 60 cc syringe and an inflation handle. The device was returned with the balloon in an un-fluted, previously inflated condition. There was a small stream of water exiting at the distal balloon joint. No part of the balloon was 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. 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. The additional information provided indicated the balloon did not receive lubrication or negative pressure 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. 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. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. A review of the complaint history was conducted. The likelihood of occurrence is considered rare. 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. 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

This report summarizes one (1) malfunction event. A review of the event indicated that during an esophageal dilatation procedure, the physician used a cook hercules 3 stage balloon esophageal. The balloon punctured during the operation at the operating room, contrast material released into the patient's esophagus. When the physician inflated the esophagus balloon during the dilatation, the balloon was punctured in the patient. The event involved a patient with no patient consequences.

 
Manufacturer Narrative

(b)(4). Concomitant product: cook ds 60 cc syringe. For the one (1) reported event, the device was returned to cook endoscopy and the operating condition was confirmed. Our evaluation of the returned device confirmed the report. The balloon was inflated with a 60 cc syringe and an inflation handle. The device was returned with the balloon in an un-fluted, previously inflated condition. There was a small stream of water exiting at the distal balloon joint. No part of the balloon was 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. 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. The additional information provided indicated the balloon did not receive lubrication or negative pressure 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. 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. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. A review of the complaint history was conducted. The likelihood of occurrence is considered rare. 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. 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

This report summarizes one (1) malfunction event. A review of the event indicated that during an esophageal dilatation procedure, the physician used a cook hercules 3 stage balloon esophageal. The balloon punctured during the operation at the operating room, contrast material released into the patient's esophagus. When the physician inflated the esophagus balloon during the dilatation, the balloon was punctured in the patient. The event involved a patient with no patient consequences.

 
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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 Key5609060
Report Number1037905-2016-00093
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 03/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2016
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/19/2016
Device Age3 mo
Event Location Hospital
Date Manufacturer Received03/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/08/2015
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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