MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HERCULES 3 STAGE BALLOON ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	G31927
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophageal dilation, the physician used a cook hercules 3 stage balloon esophageal.It was reported [that] the balloon popped.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: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo provided we cannot complete a full evaluation.The picture provided shows a small barcode label from the lot number provided attached to a sticky note.The sticky note also has "balloon popped during egd dilation" handwritten on it.The device is not visible in the picture provided.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.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.The additional information does not state if the user applied negative pressure and lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to a leakage is failure to apply negative pressure and lubrication to the balloon prior to advancement.The instructions for use advise the user: "to facilitate passage through the 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.The instructions for use also advise the user: "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 instructions for use also advises 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.A leakage can also occur if the balloon comes into contact with a sharp object or a burr in the endoscope channel.Another possible contributing factor to a leakage in the balloon material 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 balloons esophageal 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.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 24431820
• Report Number: 1037905-2026-00092
• Device Sequence Number: 13318837
• Product Code: KNQ
• UDI-Device Identifier: 00827002319271
• UDI-Public: (01)00827002319271(17)281112(10)W4986005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: G31927
• Device Catalogue Number: HBD-18-19-20
• Device Lot Number: W4986005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: UNKNOWN ENDOSCOPE MAKE AND MODEL
• Patient Sex: Unknown