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

Catalog Number HBD-W-10-11-12

Device Problems Burst Container or Vessel (1074); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook dilation syringe (ds-60cc-s) was filled with water and attached to the balloon inflation port.The syringe was placed into an inflation handle, and negative pressure was applied to the balloon.After applying negative pressure, the balloon was attempted to be inflated.The balloon would not hold pressure and leakage was seen from a rupture along the length of the balloon.A visual examination of the catheter showed kinks at approximately 158.2 cm, 160.2 cm and 163.2 cm from the distal end.It was observed that the blue switch located on the proximal end of the device had detached and was not included in the return.The wire guide associated with this device was also not included in the return of the device.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: the information provided indicated that the balloon was advanced directly into the esophagus without using an endoscope.This is against the instructions for use of the device and the most likely cause for the reported observation.The instructions for use state: "maintain balloon deflation with negative pressure and introduce into endoscope accessory channel, advancing in short increments until balloon is completely visualized endoscopically." it is also unknown what inflation device was used to inflate the balloon.A possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation resulting in damage to the balloon material.Prior to distribution, all hercules 3 stage wireguided balloons esophageal-pyloric-colonic are subjected to a visual examination 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 remote.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 the device was advanced directly into the esophagus without using an endoscope, against the instructions for use, and that the device was used on a pediatric patient when this device has not been approved for pediatric use, 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 a pediatric esophageal dilation procedure, the user selected [a cook] hercules 3 stage wireguided balloon esophageal-pyloric-colonic.Since the patient was a child, he inserted the balloon with the supplied wire guide directly into the esophagus without using an endoscope.He inflated the balloon to 10 mm for a minute at the target site first.Then, after a two-minute interval, he started to inflate the balloon again, but the balloon would not inflate properly.He removed it from the patient and found the balloon was damaged, so he replaced it with the same size of another hercules 3 stage wireguided balloon esophageal-pyloric-colonic to complete the procedure.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7365972
• MDR Text Key: 103552280
• Report Number: 1037905-2018-00110
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517950
• UDI-Public: (01)00827002517950(17)191230(10)W3812135
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-10-11-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2018
• Device Age: 14 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• 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