MAUDE Adverse Event Report: WISLON-COOK MEDICAL INC HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; DILATOR, ESOPHAGEAL

Catalog Number HBD-W-10-11-12

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2015

Event Type  malfunction  

Event Description

During an esophageal dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The balloon was inflated but would not stay inflated due to a pin hole leak in the balloon.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require and 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 was inflated with a 60 cc syringe and an inflation handle.There was a stream of water exiting the side of the balloon.The balloon would not inflate or hold pressure in this condition.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 a 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.The instructions for use state, "caution: a compromised balloon may prohibit removal from the endoscope accessory channel.Removal of the endoscope along with the compromised balloon may be required." 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 balloon is completely visualised endoscopically." "monitoring endoscopically, advance device until balloon is in the desired position within the stricture." the instructions for use contain the following 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 wireguided balloon esophageal-pyloric-colonic 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: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): WISLON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4945724
• MDR Text Key: 6256280
• Report Number: 1037905-2015-00301
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090183
• 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: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2017
• Device Catalogue Number: HBD-W-10-11-12
• Device Lot Number: W3408561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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
• Treatment: COOK DILATION SYRINGE (DS-60CC-S); OLYMPUS 180 ENDOSCOPE (UNK MODEL NUMBER)