MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; DILATOR, ESOPHAGEAL

Model Number	G51799
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag.Provided with the return was an open box from the lot number provided in the report.The label matches the product returned.Photos were provided and reviewed.The lot number in the photos matches the report.The second photo shows the device in a coiled position, and the balloon appears to be deflated.No damage to the catheter or balloon can be seen in the photo.Our laboratory evaluation of the product said to be involved confirmed the report due to a pinhole in the balloon material.The device was returned with the balloon deflated.During functional testing 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 attempted to be inflated.The balloon would not fully inflate or hold pressure, and leakage was observed from a pinhole in the proximal area of the balloon material, confirming the complaint.During a visual examination, a kink was also observed in the in the silver printed area of the catheter.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis note: the pre-loaded wire guide and stem bumper associated with this device were not included in the return.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: our laboratory evaluation of the returned device confirmed the report due to a pinhole in the balloon material.In the report it states that the balloon was used in the biliary system to dilate the bile duct.This is outside of the stated intended use and the most likely cause of the report.The ifu states, "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum, and colon." in the report it also states that negative pressure was not applied to the balloon prior to advancing down the endoscope accessory channel.Negative pressure will 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.Prior to distribution, all hercules 3 stage wire guided balloons 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that the device was used to dilate the bile duct for stone removal and negative pressure was not applied, 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 stone remove procedure in the bile duct, the user selected a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that] user advanced the balloon device through endoscope working channel to stenosis area to dilate while finding out the leaking issue.User changed to another device to continue the procedure.An image of the device showing the balloon deflated was provided.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.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 23480075
• Report Number: 1037905-2025-00751
• Device Sequence Number: 16009707
• Product Code: KNQ
• UDI-Device Identifier: 00827002517998
• UDI-Public: (01)00827002517998(17)280623(10)W4950153
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 Model Number: G51799
• Device Catalogue Number: HBD-W-8-9-10
• Device Lot Number: W4950153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SONOSCAPE, UNKNOWN MODEL
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG