MAUDE Adverse Event Report: COOK ENDOSCOPY QUANTUM TTC ESOPHAGEAL BALLOON DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number	QD-18X8
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: cook ds 60 cc dilation syringe.Investigation evaluation: our evaluation of the returned device confirmed the report.There was a split approximately 8.8 cm in length observed during attempted inflation.The balloon would not inflate or hold pressure in this condition.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.No part of the device appears to be missing.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.The reporter was unable to specify if negative pressure was applied to the balloon device prior to advancement through the accessory channel of the endoscope.A possible contributing factor to balloon damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user to apply negative pressure to the catheter to facilitate passage through the endoscope.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 possible contributing factor to balloon damage is inadequate lubrication of the balloon with a lubricating agent.The instructions for use state: "apply a water soluble lubricant to the balloon to allow easier passage through accessory channel." this activity will aid in endoscopic advancement and balloon preservation.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 balloon.¿ the instructions for use direct the user to ensure the balloon is completely visualized and positioned before inflation.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 quantum ttc esophageal balloon dilator 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook quantum ttc esophageal balloon dilator.The device was passed through the endoscope and the facility went to inflate it, and it popped.A new g22313-qd-18x8 [cook quantum ttc esophageal balloon dilator] was opened and used to complete the procedure.

• Brand Name: QUANTUM TTC ESOPHAGEAL BALLOON DILATOR
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5617305
• Report Number: 1037905-2016-00117
• Device Sequence Number: 16148399
• Product Code: KNQ
• UDI-Device Identifier: 00827002223134
• UDI-Public: (01)00827002223134(17)180916(10)W3623958
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: QD-18X8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2016
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2016
• Initial Report FDA Received Date: 04/28/2016
• Patient Sequence Number: 1