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

Catalog Number HBD-12-13.5-15

Device Problems Hole In Material (1293); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2017

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.During a functional test, a cook ds-60cc-s syringe 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, inflation of the balloon was attempted.The balloon would not hold pressure and a leakage was observed from a pinhole in the middle of the balloon material.A visual examination of the catheter showed no kinks or bends.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 a definitive cause for this observation could not be determined because the actual product preparation and handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The additional information provided indicated that the balloon was inflated prior to use.The user is advised not to inflate the balloon prior to advancement through the endoscope accessory channel.The instructions for use caution the user: "do not pre-inflate the balloon." a pinhole in the balloon material may occur if the balloon contacts something sharp during device preparation.Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual inspection and functional testing to ensure device integrity.The functional tests consist of a flow and leak test.Any nonconforming devices would have been removed prior to distribution.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.The likelihood of occurrence is considered rare.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 inflated prior to use [against the instructions for 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

In preparation for a procedure, the physician chose a cook hercules 3 stage balloon esophageal.Prior to patient contact, the user attempted to inflate the balloon to check if the balloon would inflate properly.However the balloon would not inflate and the user found the injected saline was leaking from the balloon.He replaced it with another hbd-12-13.5-15 [cook hercules 3 stage balloon esophageal] to complete the procedure.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• 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: 7022619
• MDR Text Key: 92625282
• Report Number: 1037905-2017-00682
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002319264
• UDI-Public: (01)00827002319264(17)200809(10)W3901738
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-12-13.5-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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