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

Model Number	G31927
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an unknown endoscopic procedure, the physician used a cook hercules 3 stage balloon esophageal.It was reported [that] the balloon popped during dilation while in the patient.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 clear plastic biohazard 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.The balloon returned with the balloon deflated and multiple kinks in the catheter.The kinks were located 49.4 cm, 59.8 cm, 76.5 cm, 154.9 cm, and 158.5 cm from the distal end of the white strain relief.A functional test could not be performed due to the condition of the returned device.A close visual examination identified a rupture in the balloon material.The rupture is located in the proximal portion of the balloon and no portion of the device or balloon material appear to be missing.No other anomalies were detected with the device.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 the report due to a rupture/split in the balloon material.A definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.A leakage/damage to the balloon material can 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 (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: 21574183
• Report Number: 1037905-2025-00200
• Device Sequence Number: 15510241
• Product Code: KNQ
• UDI-Device Identifier: 00827002319271
• UDI-Public: (01)00827002319271(17)271114(10)W4888589
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/11/2025

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: G31927
• Device Catalogue Number: HBD-18-19-20
• Device Lot Number: W4888589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 11/14/2024
• 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: COOK SPHERE INFLATION DEVICE; UNKNOWN ENDOSCOPE MAKE AND MODEL
• Patient Sex: Unknown