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

Model Number	G31511
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook dilation syringe, ds-60cc-s.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.A leakage in the balloon can occur if the balloon material comes into contact with a sharp object or a burr in the endoscope channel.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 dilators 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 esophageal dilation procedure, the physician used a cook quantum ttc esophageal balloon dilator.The balloon was not holding water pressure appropriately, and began to leak at the proximal end of the balloon.The procedure was successfully completed with another balloon of the same type.

• 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: 7266273
• Report Number: 1037905-2018-00051
• Device Sequence Number: 11288622
• Product Code: KNQ
• UDI-Device Identifier: 00827002315112
• UDI-Public: (01)00827002315112(17)201101(10)W3935586
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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 Model Number: G31511
• Device Catalogue Number: QD-20X8
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2018
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1