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

Model Number	G31511
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook dilation syringe (ds-60cc-s), boston scientific alliance inflation device.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test was performed and the balloon was attempted to be inflated with water using a cook ds-60cc-s dilation syringe.The balloon could not be inflated and a leakage was observed from a rupture on the proximal side of the balloon material.The catheter did not show any kinks or bends.No portion of the device appeared to be 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 conclusion: the additional information received indicated that negative pressure and lubrication was not applied to the balloon prior to advancement through the endoscope accessory channel.This is the most likely cause for the reported observation.A contributing factor to balloon damage is failure to apply negative pressure and lubrication to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user under precautions: "prior to insertion of balloon dilator, negative pressure is mandatory 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 advise the user: "apply a water soluble lubricant to balloon to allow easier passage through accessory channel." this activity will aid in endoscopic advancement and balloon preservation.Additional information also indicated that the balloon was inflated prior to patient contact.This is another likely cause for the reported observation.The instructions for use caution the user: "do not pre-inflate balloon." 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 and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that negative pressure and lubrication were not applied and that the balloon was inflated prior to use, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During an endoscopic procedure, the physician used a cook quantum ttc esophageal balloon dilator.The device popped during use.The following additional information was received from the clinical specialist on 29 aug 2019: "it sounds like they were filling the balloon up, when the luer connection between the balloon and the dilation syringe disconnected.After reconnecting the two, they proceeded to inflate the balloon but when it got to 40 psi, the balloon popped." 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.

• 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: 9088073
• Report Number: 1037905-2019-00551
• Device Sequence Number: 19537944
• Product Code: KNQ
• UDI-Device Identifier: 00827002315112
• UDI-Public: (01)00827002315112(17)220702(10)W4233342
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/27/2019

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 Expiration Date: 07/02/2022
• Device Model Number: G31511
• Device Catalogue Number: QD-20X8
• Device Lot Number: W4233342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1