MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HERCULES 3 STAGE BALLOON ESOPHAGEAL; DILATOR, ESOPHAGEAL

Catalog Number HBD-18-19-20

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 04/23/2015

Event Type  Injury  

Event Description

During an esophageal dilation procedure, the physician used a cook hercules 3 stage balloon.Upon completion of an esophageal dilation procedure, when the physician inflated the balloon to 6 atm (20 mm) the balloon burst.The physician removed the device and retrieved all fragments.As this was at the end of the procedure, no other device was used.A section of the device did not remain inside the patient's body.Other than retrieving the device fragments, 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 evaluation of the returned device confirmed the report.The balloon and balloon tip was returned separated from the catheter.There is a 1 cm section of balloon still attached at the proximal balloon joint.There is adhesive present on the wire where the balloon tip attached.Due to the condition of the returned device it cannot be determined if a small section less than 1 cm of the balloon is missing.There is a minor kink in the catheter approximately 55 cm from the hub.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 accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically.Monitor endoscopically until the 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 balloons are subjected to a visual inspection and functional testing 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.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4792548
• MDR Text Key: 5802163
• Report Number: 1037905-2015-00207
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Catalogue Number: HBD-18-19-20
• Device Lot Number: W3542235
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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: COOK DS-60CC-S DILATION SYRINGE; BOSTON SCIENTIFIC ALLIANCE GUN; OLYMPUS ENDOSCOPE (UNK MODEL)
• Patient Outcome(s): Required Intervention