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

Model Number 611940

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Balloon being prepped before entering the body.Balloon popped during prep time without full amount of liquid in balloon.

• Brand Name: TYSHAK II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): B BRAUN INTERVENTIONAL SYSTEMS, INC; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 10349511
• MDR Text Key: 201168662
• Report Number: 10349511
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04046964339417
• UDI-Public: (01)04046964339417(17)250131(10)TT-15678
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2020,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 611940
• Device Catalogue Number: 611940
• Device Lot Number: TT-15678
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1