MAUDE Adverse Event Report: B BRAUN INTERVENTIONAL SYSTEMS, INC TYSHAK II; CATHETER, PERCUTANEOUS

Model Number	611940
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon being prepped before entering the body.Balloon popped during prep time without full amount of liquid in balloon.

• Brand Name: TYSHAK II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): B BRAUN INTERVENTIONAL SYSTEMS, INC; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 10349511
• Report Number: 10349511
• Device Sequence Number: 2345326
• Product Code: DQY
• UDI-Device Identifier: 04046964339417
• UDI-Public: (01)04046964339417(17)250131(10)TT-15678
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/14/2020
• Report Date (Section F): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 611940
• Device Catalogue Number: 611940
• Device Lot Number: TT-15678
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2020