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

Model Number	G51798
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the video and pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A picture of the lot number was not provided.Our evaluation of the video and pictures provided confirmed the report.The video shows the device outside of the endoscope, and water can be seen leaking out of a break in the blue catheter, confirming the complaint.The distal end of the balloon has also been cut.Based on the video provided, we were unable to determine the exact location of the catheter crack/breakage.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 evaluation of the provided photos and videos confirmed the report.A corrective action (capa) has been initiated to reduce occurrences of catheter cracking, splitting, or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.In the report it does not state if negative pressure and/or lubrication was applied to the balloon prior to advancement through the endoscope.Negative pressure and applying lubrication 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 "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel" and 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: a corrective action (capa) has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.A review of the complaint history was conducted.Of product distributed during this time period.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an esophageal dilation, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that] the catheter ruptured, leading to balloon deflation.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; winston salem 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: 22998259
• Report Number: 1037905-2025-00648
• Device Sequence Number: 12990240
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)270723(10)W4856039
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/08/2025

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: G51798
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W4856039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ENDOSCOPE MAKE AND MODEL
• Patient Sex: Male