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

Catalog Number HBD-15-16.5-18

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: boston scientific alliance inflation device.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, a cook 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 inflated water.When the balloon started filling up with water, a pinhole was observed in the middle of the balloon material.There were no kinks observed throughout the length of the catheter.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 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: ¿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 balloon damage is application of inadequate 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.The instructions for use direct the user: ¿maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically.¿ damage to 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 contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure.¿ over inflation can cause damage to the balloon dilator.Another 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, possibly resulting in damage to the balloon material.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

On 01/12/2017, we received the following information: during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook hercules 3 stage balloon esophageal.The device was used to dilate stenosis of the cardiac region of stomach after total gastric resection.When the physician attempted to inflate the balloon to 16.5 mm after the first inflation with 15 mm in the target site, the balloon would not inflate.A pinhole is suspected.Then, the device was removed from the patient and replaced with another manufacturer's device.The patient had a favourable outcome.The complaint did not include reportable information at that time.Additional information was received on 01/25/2017: the device was used to dilate stenosis from the distal side of the esophagus to the anastomosis site with the cardiac region of stomach after total gastric resection.On 01/26/2017, the device was received.A pinhole was confirmed.

• 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: 6339130
• MDR Text Key: 67814746
• Report Number: 1037905-2017-00062
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002487321
• UDI-Public: (01)00827002487321(17)181208(10)W3657795
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-15-16.5-18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2017
• Device Age: 13 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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: OLYMPUS ENDOSCOPE, UNKNOWN MODEL