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

Model Number	G22313
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	12/21/2018
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: the additional information received indicated that the balloon was inflated beyond the maximum labeled inflation pressure.The instructions for use warn the user: "recommended 100% balloon inflation pressure can be found on q.I.D.And on catheter tag of balloon dilator." inflation of the device beyond maximum labeled inflation pressure can contribute to leakage in the balloon material.This is the most likely cause for the reported observation.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 the balloon was inflated beyond the maximum labeled inflation pressure, a cook representative has been directed to contact 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 esophagogastroduodenoscopy (egd), the physician used a cook quantum ttc esophageal balloon dilator.When the device began inflating, it reached around 4 atm (atmosphere); at this point, a pinhole leak was noticed.The device was removed and another of the same device was used to complete the procedure.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: 8249897
• Report Number: 1037905-2019-00018
• Device Sequence Number: 19364156
• Product Code: KNQ
• UDI-Device Identifier: 00827002223134
• UDI-Public: (01)00827002223134(17)211029(10)W4137405
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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 Expiration Date: 10/29/2021
• Device Model Number: G22313
• Device Catalogue Number: QD-18X8
• Device Lot Number: W4137405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1