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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL

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COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-W-12-13.5-15
Device Problems Hole In Material; Leak / Splash
Event Date 11/22/2017
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products. Olympus endoscope - model unknown. Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. A functional test was performed on the returned device. A cook dilation syringe (ds-60cc-s) 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, the balloon was inflated with water and the balloon would not hold pressure. A leak was seen from a pinhole in the middle of the balloon. A visual inspection of the catheter showed no kinks/bends. The pre-loaded wire guide was included in the return. 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. It is unknown if the user applied negative pressure to the balloon prior to advancement down the endoscope accessory channel. A possible contributing factor to a leakage in the balloon material is failure to apply negative pressure to the balloon prior to advancement through the endoscope. The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device. " 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. The instructions for use also advise the user: ¿maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically. ¿ a leakage in the balloon can also occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel. 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. " 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 wireguided balloon esophageal-pyloric-colonic 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. 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 chose a hercules 3 stage wireguided balloon esophageal-pyloric-colonic. The wire guided balloon snapped during the procedure. Additional clarifying information received 11/28/2017 indicated that when filling the balloon, the physician was unable to get pressure on the device. The balloon leaked. The customer has used the balloon for three years and has never had this problem. (b)(6).

 
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Brand NameHERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
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 Key7122897
Report Number1037905-2017-00760
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-W-12-13.5-15
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/22/2017
Device Age1 yr
Event Location Hospital
Date Manufacturer Received11/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2016
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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