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

Catalog Number HBD-W-18-19-20

Device Problem Fracture (1260)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in 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 device was returned with the balloon detached/cut off.The device was measured and the catheter was bent/kinked at 106.5cm, and broken at 119.2cm, 230.3cm and with the balloon cut off at 242.4cm.The distal end of the balloon joint was measured using the ring gauge and there was some difficulty with ring gauging distal end.The proximal end of the device could not be measured using ring gauge due to the damage with the device.In addition, the balloon was cut so balloon inflation could not be confirmed.A lab meeting was held with production management and production engineering on 14 february 2024, and the device was examined.The distal end of the balloon did not pass the ring gauge test due to the thickness of the distal end of the balloon.During the lab meeting it was confirmed that there was too much glue at the distal joint and there was not a smooth transition at the balloon to catheter joint.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: 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.Our laboratory evaluation confirmed the report for catheter breakage which can cause difficulty with device deflation and removal, but also confirmed that there was excessive glue on the distal balloon to catheter joint.The cause of this is the application of excessive glue during the manufacturing process.This nonconformance occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management.Retraining will be completed to address this occurrence.Additional information received did not state if negative pressure or lubrication was applied to the balloon prior to advancement through the endoscope.Negative pressure will aid in balloon preservation and optimize balloon performance.The instructions for use direct the user "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." "to facilitate passage through the endoscope, apply negative pressure to the device." in addition, the user is further instructed 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.

Event Description

During an unknown endoscopic procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.It was reported [that the balloon] dilator [was] difficult to get through scope, unable to withdraw once balloon deflated.The scope was then removed from the patient and device was cut to safely remove from scope.Had to do each dilation 3 times.There was no reportable information at this time.The device was evaluated on 30jan2024.The catheter was broken at 119.2cm and 230.3cm [subject of report] and with the balloon cut off at 242.4cm.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): 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: 18771431
• MDR Text Key: 336177371
• Report Number: 1037905-2024-00103
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W4769901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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: UNKNOWN ENDOSCOPE