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

Model Number	G51795
Medical Device Problem Codes	Fluid/Blood Leak (1250); Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: inflation device, unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual examination showed that the device was bent approximately 8 cm from the distal end.During a functional test, a cook dilation syringe ((b)(4)) 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, inflation of the balloon was attempted.The balloon would not hold pressure and a leakage was observed from a pinhole on the distal side of the balloon component.It was observed that the blue switch and clear adapter were missing and not included in the return.The pre-loaded wire guide was also not included in the return.A discrepancy or anomaly that could have contributed to the reported event was not observed during our laboratory analysis of the returned product.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.In addition, 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 information provided indicated that the balloon was used during sphincteroplasty of the papilla.The intended use of the device is as follows: "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon." the instructions for use state: ¿do not use this device for any other purpose other than stated intended use." a pinhole in the balloon can occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel.The information provided indicated a pressurizer was used to inflate the balloon.The make and model of the pressurizer is unknown.A possible contributing factor to balloon material damage 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 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.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 the device was being used to dilate the papilla [off label use], 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 a duodenal papillary dilation [off label use], the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user found that the balloon was leaking during use.The user changed to another of the same device to complete the procedure.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
Initially, the following information was reported to cook: during a duodenal papillary dilation [off label use], the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The user found that the balloon was leaking during use.The user changed to another of the same device to complete the procedure.Additional information was received 22-apr-2019 confirming that the balloon was used for duodenal dilation.Therefore, this event no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This correction follow up report is being sent to cancel the initial report submitted related to this event.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8487276
• Report Number: 1037905-2019-00177
• Device Sequence Number: 1899997
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)210827(10)W4109991
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 08/27/2021
• Device Model Number: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4109991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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 TFTYGE 260V ENDOSCOPE.
• Patient Age: 87 YR