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

Catalog Number	HBD-12-13.5-15
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test a cook ds-60cc-s syringe was filled with water and attached to an inflation handle.The handle was then attached to the inflation port of the balloon.Once negative pressure was applied, as the balloon filled with water, a visual observation was made and water was leaking out of a pinhole near the distal end of the balloon.No portion of the balloon material was missing.There were no kinks or bends in the catheter.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 conclusions: 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 reporter was unable to specify if the balloon was lubricated prior to advancement through the accessory channel of the endoscope.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 reporter was unable to specify if negative pressure was applied to the balloon device prior to advancement through the accessory channel of the endoscope.Another possible contributing factor to balloon damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user: "to facilitate passage through endoscope, apply negative pressure to the catheter." 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.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 or Problem Description
During an endoscopy procedure, the physician used a cook hercules 3 stage balloon esophageal.As reported to cook customer relations: "the balloon ruptured at the last stage of inflation.".

• 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: 5989904
• Report Number: 1037905-2016-00377
• Device Sequence Number: 13582980
• Product Code: KNQ
• UDI-Device Identifier: 00827002319264
• UDI-Public: (01)00827002319264(17)190621(10)W3736719
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2016

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 Catalogue Number: HBD-12-13.5-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 09/30/2016
• 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: ENDOSCOPE (UNKNOWN TYPE)