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

Model Number	G51799
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During an unknown endoscopic procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that] during the procedure, the staff felt something snap.On further examination it was noticed the outer sheath was broken/snapped.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.
Additional Manufacturer Narrative
E1 - country: united kingdom e1 - postal code: (b)(6).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: 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.It is unknown 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.Quality assurance will continue to monitor for complaint trends.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC
• 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 ; 3367440157
• MDR Report Key: 21312238
• Report Number: 1037905-2025-00098
• Device Sequence Number: 8169347
• Product Code: KNQ
• UDI-Device Identifier: 00827002517998
• UDI-Public: (01)00827002517998(17)270805(10)W4859423
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: G51799
• Device Catalogue Number: HBD-W-8-9-10
• Device Lot Number: W4859423
• 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: 01/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 08/05/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown