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

Catalog Number HBD-W-12-13.5-15

Device Problems Hole In Material (1293); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: cook ds-60-cc-s dilation syringe, boston scientific alliance inflation handle.For the one (1) reported event, the device was returned to cook endoscopy.Our laboratory evaluation of the product said to be involved confirmed the report.The balloon was returned with the distal tip disconnected from the balloon.The distal tip was still on the device and the wire guide was still in the device upon return.A functional test was performed on the balloon using a 60 cc syringe and an inflation handle.During inflation of the balloon, the balloon would not hold pressure due to the distal tip being separated.There appeared to be glue present where the distal tip is connected to the balloon.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 dilator did not receive 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 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.A possible contributing factor to balloon damage 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 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 a vacuum "and remove all fluid from the balloon while observing the balloon endoscopically." then, the user is instructed to "remove the deflated balloon from accessory channel." the application of a vacuum will aspirate all residual fluid from the balloon and ease removal of the balloon from the endoscope.If these instructions are not followed, this could have contributed to the reported observation.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic 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.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.Additional comments regarding this report: based on the information provided, a cook representative has contacted 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 this event indicated that during an esophageal dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.After dilation, when the physician tried to remove the balloon from the endoscope, he felt much resistance.He stopped and removed it [the balloon] together with the endoscope.When it was outside the patient, the physician noticed the plastic sheath connected to the tip of the balloon was detached.He tried to inflate the balloon but failed; water leaked from the tip of the balloon.The one (1) event involved a patient with no consequences.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, 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 Key: 5808288
• MDR Text Key: 49969750
• Report Number: 1037905-2016-00208
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517967
• UDI-Public: (01)00827002517967(17)170423(10)W3420427
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: HBD-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 Date: 04/04/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF-H180 ENDOSCOPE
• Patient Age: 60 YR