MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) ECLIPSE TTC WIRE GUIDED BALLOON DILATOR; DILATOR, ESOPHAGEAL

Model Number	G25630
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an duodenal papilla stricture dilation the physician used a cook eclipse ttc wire guided balloon dilator.It was reported that the user attempted to inflate the balloon with water and discovered the balloon leaking issue.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
Investigation evaluation: the product said to be involved was returned in a white plastic bag.Provided with the return was an open box and pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the balloon deflated.During functional testing a cook dilation syringe (ds-60cc-s) from our shelf stock was filled with water and attached to the balloon inflation port.During inflation, a leak was observed from the distal portion of the balloon material.A close visual examination identified a small rupture in the balloon material.No portion of the device or balloon material appears to be missing, and no other anomalies were detected with the device.Note: the stylet was not included in the return.The device history record for the lot number said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: our evaluation of the returned device confirmed the report due to a rupture/split in the distal end of the balloon material.In the report, it states the balloon was used to dilate the duodenal papilla [sphincteroplasty].This area is not intended for the use of this device and is the most likely cause for the reported observation.The intended use in the instructions for use states: "this device is used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon." the indications for use listed in the ifu are as follows "these devices are accessory endoscopic devices used to treat adult patients with esophageal strictures, gastric strictures, and colonic strictures of the gastrointestinal tract.This does not include balloons used for dilation of the biliary tree or in the treatment of achalasia", it also states "do not use this device for any purpose other than stated intended use." prior to distribution, all eclipse ttc wire guided balloon dilators 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.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Quality assurance will continue to monitor for complaint trends.Additional comments: based on the information provided that the balloon was used to dilate the duodenal papilla [sphincteroplasty], 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: ECLIPSE TTC WIRE GUIDED BALLOON DILATOR
• 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: 25430754
• Report Number: 1037905-2026-00267
• Device Sequence Number: 10205128
• Product Code: KNQ
• UDI-Device Identifier: 00827002256309
• UDI-Public: (01)00827002256309(17)280401(10)W4926857
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: G25630
• Device Catalogue Number: ECL-12X5.5
• Device Lot Number: W4926857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: OLYMPUS TJF-260V
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG