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 balloon was returned and appeared to not have been inflated.There were kinks in the catheter at 126.3cm and 128.6cm with a break at the 126.3cm section distal from the handle.During a ring gauge test the distal end passed the ring gauge however the proximal end did have difficulty.There were no other anomalies detected with this device.A lab meeting was held with production management and production engineering on (b)(6) 2024, and the device was examined.The balloon was measured using the ring gauge and it passed the gauge test on the distal end of the balloon.The proximal end of the balloon did not pass the ring gauge test due to the thickness of the proximal end of the balloon.During the lab meeting it was confirmed that there was too much glue at the proximal 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, but also confirmed that there was excessive glue on the proximal 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.In the report it does not state if negative pressure and lubrication were applied to the balloon prior to advancing down the endoscope accessory channel.The ifu states: "to facilitate passage through the endoscope, apply negative pressure to the device." "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." 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.This device was returned with the balloon that appeared to not have been inflated.There was a break at the 126.3cm section distal from the handle [subject of report].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: 18771920
• MDR Text Key: 337014032
• Report Number: 1037905-2024-00104
• 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: W4768763
• 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: 09/27/2023
• 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.