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

Catalog Number HBD-12-13.5-15

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: boston scientific inflation handle, cook ds-60cc-s syringe.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A ds-60cc-s syringe was included in the return.During our evaluation of the device a functional test was performed.A ds-60cc-s syringe was filled with water, placed in an inflation handle and attached to the balloon port.When pressure was applied, a pinhole in the balloon material was observed.The pinhole was on the proximal end of the balloon.No section of the balloon material appeared to be missing.There were no kinks or bends in the catheter observed.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 conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.A possible contributing factor to a hole in the balloon material is inadequate lubrication of the balloon with a lubricating agent.The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.Another possible contributing factor to a hole in the balloon material is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.A hole in the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon.¿ the instructions for use direct the user to "monitor endoscopically until the balloon is in the desired position within the stricture." prior to distribution, all hercules 3 stage balloon esophageal 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: 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.

Event Description

During an esophageal dilation, the physician used a cook hercules 3 stage balloon esophageal.The user added six (6) atm of pressure to inflate the balloon to fifteen (15) mm, following twelve (12) mm, and 13.5 mm, but the balloon would not inflate.He [the physician] deflated once and attempted to inflate again, but confirmed the balloon would not inflate due to leak from a pinhole.Another hercules 3 stage balloon esophageal was used instead 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: 6053429
• MDR Text Key: 58454579
• Report Number: 1037905-2016-00429
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002319264
• UDI-Public: (01)00827002319264(17)190425(10)W3713494
• 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: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• 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: 09/29/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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
• Treatment: ENDOSCOPE (UNKNOWN TYPE)