MAUDE Adverse Event Report: WILSON COOK MEDICAL INC. ERHCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Catalog Number HBD-W-10-11-12-J

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic was used.During balloon inflation, the physician noticed that the balloon would not inflate and diluted contrast media was leaking at the connector.Another of the same device was used to complete the procedure.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the returned product confirmed the report.The balloon was inflated with a 60 cc syringe and an inflation handle.When the balloon is inflated with water a small and steady stream of water exits the balloon.The balloon will not hold pressure in this condition.According to the report the device was leaking at the connector.Since the balloon exhibited a small pinhole, a clamp was applied to the catheter to provide enough back pressure to test the connector for leaks.The catheter was clamped and the pressure was increased to 6 atm.No leakage was observed at the proximal connectors.No part of the device is missing.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 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 balloon material failure 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 allow easier passage through the accessory channel.This activity will aid in endoscopic advancement and balloon preservation.The instructions for use advise the user that negative pressure is needed to maintain balloon deflation.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 balloon material failure 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 state, "maintain balloon deflation with negative pressure and introduce into the endoscope channel, advancing in short increments until the balloon is completely visualized endoscopically." "monitoring endoscopically, advance device until balloon is in the desired position within the stricture." the instructions for use contain the following warning: during dilation do not inflate balloon beyond the maximum indicated inflation pressure, as this could result in overextension or bursting of the balloon.To achieve increasingly larger balloon diameters, increase pressure as indicated on the catheter tag.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 a failure of the balloon material.Prior to distribution, all hercules 3 stage esophageal wireguided balloons are subjected to a visual inspection and functional testing to ensure device integrity.The functional tests consist of a flow and leak test.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.

• Brand Name: ERHCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4632525
• MDR Text Key: 15317349
• Report Number: 1037905-2015-00114
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2017
• Device Catalogue Number: HBD-W-10-11-12-J
• Device Lot Number: W3424071
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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: MODEL #UNK