MAUDE Adverse Event Report: COOK INCORPORATED QUANTUM TTC; DILATOR, ESOPHAGEAL

Model Number	G31511
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the esophageal balloon dilator popped while in process of stage 2 inflation (from 60 psi to 90 psi.It was noticed and immediately removed from the patient without difficulty.There was no harm to the patient.

• Brand Name: QUANTUM TTC
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7432354
• Report Number: 7432354
• Device Sequence Number: 16513054
• Product Code: KNQ
• UDI-Device Identifier: 00827002315112
• UDI-Public: (01)00827002315112(17)20101010(10)W3924453
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018
• Report Date (Section F): 03/30/2018

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: Physician
• Device Expiration Date: 10/10/2020
• Device Model Number: G31511
• Device Catalogue Number: QD-20X8
• Device Lot Number: W3924453
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NOT APPLICABLE.
• Patient Age: 76 YR
• Patient Weight: 52
• Date Report Sent to FDA: 03/30/2018