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

Model Number	G22312
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A functional test could not be performed due to the condition of the returned device.A visual examination showed a rupture along the length of the balloon material.The catheter did not show any kinks/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 contains non-conformances that could potentially be related to balloon rupture.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.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
In preparation for a procedure, the user selected a cook quantum ttc esophageal balloon dilator.During the preparation, the technician was applying negative pressure and it was not holding.He then inflated it to see what was going on and there was a tear in it.The device did not make patient contact.The procedure was successfully completed with another device of the same type.This occurred prior to patient contact; there was no impact to the patient.

• 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: 8484678
• Report Number: 1037905-2019-00175
• Device Sequence Number: 1921759
• Product Code: KNQ
• UDI-Device Identifier: 00827002223127
• UDI-Public: (01)00827002223127(17)201010(10)W3927757
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/11/2019

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: 10/10/2020
• Device Model Number: G22312
• Device Catalogue Number: QD-16X8
• Device Lot Number: W3927757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1