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

Model Number	G48732
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: alliance inflation gun.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.In the additional information provided, it is indicated that lubrication and negative pressure were not applied to the balloon prior to advancement through the endoscope.A possible contributing factor to balloon material damage is failure to lubricate the balloon with a lubricating agent.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.Another possible contributing factor to a leak in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use direct the user " to facilitate passage through the endoscope, apply negative pressure to the device." in addition, the user is further instructed to "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Failure to apply negative pressure and lubrication is the likely cause of the device failure.Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual examination and leak test 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: 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.Information regarding in-service request: based on the information provided that lubrication and negative pressure were not applied to the balloon prior to advancement through the endoscope, 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 or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was inflated and deflated twice, then moved to another position in the esophagus.The balloon was inflated again to 15 mm and while inflating to 18 mm the balloon ruptured.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.
Event or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was inflated and deflated twice, then moved to another position in the esophagus.The balloon was inflated again to 15 mm and while inflating to 18 mm the balloon ruptured.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.
Additional Manufacturer Narrative
Information regarding d11: alliance inflation gun.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 observed from 3 pinholes near the proximal end of the balloon material.There were no kinks or any other damage to the catheter.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.However, in the additional information provided, it is indicated that lubrication and negative pressure were not applied to the balloon prior to advancement through the endoscope.A possible contributing factor to balloon material damage is failure to lubricate the balloon with a lubricating agent.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.Another possible contributing factor to a leak in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use direct the user " to facilitate passage through the endoscope, apply negative pressure to the catheter." in addition, the user is further instructed to "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." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Failure to apply negative pressure and lubrication is the likely cause of the device failure.Prior to distribution, all hercules 3 stage balloons esophageal are subjected to a visual inspection and functional testing to ensure device integrity.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.Corrective action: 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 that lubrication and negative pressure were not applied to the balloon prior to advancement through the endoscope, 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.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9884297
• Report Number: 1037905-2020-00159
• Device Sequence Number: 19413369
• Product Code: KNQ
• UDI-Device Identifier: 00827002487321
• UDI-Public: (01)00827002487321(17)220611(10)W4224860
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: G48732
• Device Catalogue Number: HBD-15-16.5-18
• Device Lot Number: W4224860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 190 SERIES GASTROSCOPE