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

Model Number	G51795
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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 due to a pinhole in the balloon material.The device was returned with the balloon deflated and an unknown dried substance, likely contrast, was within the balloon.During functional testing, a cook dilation syringe (ds-60cc-s) was filled with water and attached to the balloon inflation port.When tested as returned the balloon would not inflate, likely due to the dried substance within the device/balloon.The device was soaked in hot water, then placed into cidex for decontaminated, in an attempt to clear the blockage, however the balloon still would not inflate.In order to bypass the blockage in the device, and perform functional testing, the balloon was cut from the catheter near the distal end.An inflation attachment was then placed on the cut end of the catheter in order to attach a water filled ds-60cc syringe from our shelf stock to the device and the distal tip of the balloon was pinched closed.When tested 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.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 on/off wire guide switch associated with this device was 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 evaluation of the returned device confirmed balloon leakage 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 does not state if negative pressure and lubrication were applied to the balloon prior to advancing down the endoscope accessory channel.The ifu states: "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." 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 balloon was used in the biliary system to dilate the bile duct, 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 an endoscopic procedure in the bile duct, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was [reported] that the user detected the balloon leaking issue during use, and changed to another one to continue 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.

• 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
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 21913313
• Report Number: 1037905-2025-00337
• Device Sequence Number: 18489448
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)260907(10)W4762637
• 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): 04/25/2025

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
• Device Expiration Date: 09/07/2026
• Device Model Number: G51795
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W4762637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 09/07/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK METII-35-480; OLYMPUS DUODENOSCOPY
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG