MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HERCULES 100 3 STAGE WIRE GUIDED BALLOON; DILATOR, ESOPHAGEAL

Model Number	G35271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 report indicates that negative pressure was not applied to the device prior to advancement through the endoscope.A possible contributing factor to a leak in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use direct the user: "apply negative pressure to the device to facilitate removal of the protective sleeve." in addition, the user is further instructed to: "maintain negative pressure and introduce the device over the wire guide, advancing in short increments until the balloon is completely visualized endoscopically." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.In addition, it was reported the device was making contact with a metallic device during use, this could have contributed to creating a leak in the balloon.Prior to distribution, all hercules 100 3 stage wire guided balloons 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 review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that negative pressure was not applied, 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 a transoral esophageal dilation, the physician used a cook hercules 100 3 stage wire guided balloon.It was reported [that] the balloon blew up to the first stage at 2 atm and then they took the balloon out, reinserted and inflated to the 2nd stage at 4 atm.The user stated "the balloon was hitting the transoral metal inserter when inflated (not sure if this is what it's called) and started being unable to hold the atm".They deflated and took out the balloon.Blew up the balloon outside of the patient and there was a small hole in the balloon.The user explained that they think it is due to the balloon hitting the metal inserter but feels there is no way to be sure.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 100 3 STAGE WIRE GUIDED BALLOON
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 16826983
• Report Number: 1037905-2023-00191
• Device Sequence Number: 6849663
• Product Code: KCF
• UDI-Device Identifier: 00827002352711
• UDI-Public: (01)00827002352711(17)240924(10)W4518632
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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 Expiration Date: 09/24/2024
• Device Model Number: G35271
• Device Catalogue Number: HBDE-W-18-19-20
• Device Lot Number: W4518632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - TRANSORAL RIGID SCOPE & LARYNGOSCOPE
• Patient Sex: Male