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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-18-19-20
Device Problems Crack; Product Quality Problem; Use of Device Problem
Event Date 06/13/2018
Event Type  Malfunction  
Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report as it was described and confirmed a crack in the catheter. A functional test could not be performed on the balloon because a crack was observed in the catheter. During our laboratory evaluation, the balloon was lubricated and attempted to be advanced down an olympus gif-q20 endoscope with a 2. 8 mm channel. Difficulty was experienced while advancing the balloon. A visual examination of the catheter showed a crack approximately 23 cm from the distal end. A kink was also observed approximately 115. 5 cm from the distal end. A laboratory meeting was conducted with members of production to investigate advancement difficulty through the endoscope accessory channel. An examination of the area between the purple tubing and blue catheter showed the absence of glue. It was confirmed that this could have contributed to advancement difficulty of the balloon through the endoscope accessory channel. The lot number w4046361 was researched to check if any product was in our possession. All product from this lot had been shipped out to the customer. Additionally, the sub assembly lot number involved was used to determine if there were any finished goods lots that were in our possession. All product from this sub assembly lot had been shipped out to the customer. 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: the user indicated difficulty during advancement of the balloon. During our laboratory investigation, difficulty with advancement was confirmed. It was also discovered that there was absence of glue at the area between the purple tubing and the catheter which could have contributed to the advancement difficulty. This is the root cause for the reported observation. The manufacturing instruction ensures that there is adhesive present between the purple tubing and the distal end of the blue catheter. If the purple tubing does not remain attached to the blue catheter, this will be considered nonconforming. The additional information provided indicated the balloon dilator did not receive lubrication prior to advancement through the endoscope. The instructions for use direct the user, "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. During our laboratory investigation it was also observed that the catheter was cracked. Damage to the catheter can occur if the device experiences excessive pressure, which could have occurred while the users attempted to pass the device into the endoscope. Prior to distribution, all hercules 3 stage wire guided balloons 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 currently being assessed and a follow up report will be sent. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available. Additional comments regarding this report: based on the information provided that lubrication was not applied to the device, 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

During an esophagogastroduodenoscopy, the physician used a cook hercules 3 stage wireguided balloons esophageal-pyloric-colonic. The device would not fit down the endoscope channel. They switched from an olympus q190 endoscope to an olympus q180 endoscope and still had the same problem (2. 8 mm channel size for both endoscopes). This problem occurred with three (3) different devices [each from different lots] in the same case. They went to a smaller sized balloon, and it was successful. They successfully finished the case by dilating up to 18 mm. There was no reportable information at this time. The device was received and evaluated on 19-jun-2018 and was found to have a crack in the catheter. A section of the device did not remain inside the patient's body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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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 (Section G)
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 Key7687387
Report Number1037905-2018-00314
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-W-18-19-20
Device LOT NumberW4046361
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2018
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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