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

Catalog Number HBD-W-15-16.5-18

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.The pre-loaded wire guide was not included in the return.Our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.The device was returned with the balloon cut from the catheter at 227cm and the catheter was kinked and broken.A visual inspection of the device identified a kink in the catheter at 191cm from the distal end of the white strain relief.A break in the catheter was identified approximately 107cm from the distal end of the white strain relief.The catheter also appeared to be partially cut near the silver printed area of the catheter body.During the evaluation an inflation attachment was placed on the cut end of the catheter in order to attach a syringe from our shelf stock to the device for functional testing of the balloon.The syringe was filled with water and the distal tip of the balloon was pinched closed.The balloon was able to be inflated and deflated fully.No leaks from the balloon were detected.When removing the inflation attachment the partially cut portion of the blue catheter (near the silver printed area) detached.Both glue joints, where the balloon meets the catheter and the distal tip to balloon joint, were also measured with the appropriate ring gauges and both joints passed the gauge test.No portion of the catheter or balloon material appears to be missing and 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.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 states that negative pressure and lubrication were not applied to the balloon prior to advancing down the endoscope accessory channel.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 has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.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: based on the information provided that negative pressure and lubrication were not applied to the balloon prior to advancing down the endoscope accessory channel, 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 Description

During an esophageal dilation, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was initially reported that the user was unable to deflate the balloon enough to pull it back into the scope.The balloon was pulled into the scope without being fully deflated, and the scope and device were removed as a unit.The balloon catheter was cut in order to remove it from the scope once outside of the patient.This malfunction has not historically cause harm to the patient so it was initially considered not reportable.The device returned and was evaluated on (b)(6) 2024.The blue catheter was observed to be broken approximately 107 cm from white strain relief making this a reportable malfunction.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
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 19002999
• MDR Text Key: 339253573
• Report Number: 1037905-2024-00188
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 10827002517971
• UDI-Public: (01)10827002517971(17)260505(10)W4725087
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-15-16.5-18
• Device Lot Number: W4725087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE-OLYMPUS GIF-H2-190